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 12/16/2025 has been entered: Claims 1-23 are pending in the present application. Claims 1, 2, 4, 5, 9, 13-17, and 19-20 are amended. Claims 21-23 are new.
Applicant’s amendments have been acknowledged, and overcome each and every 112(b) rejection, and objection to the drawings, specification, and claims previously set forth in the non-final office action mailed 10/21/2025. All previous objections and 112(b) rejections have been withdrawn.
Response to Arguments
Applicant's arguments filed 12/16/2025, with respect to the combination of Norris and Young have been fully considered but they are not persuasive.
Applicant argues Norris cannot be modified by the teachings of Young as such a modification would change the principle of operation of Norris as Norris is directed to providing discrete access to the upper torso and lower regions of the patient’s body, while Young is intended to prevent such access.
However, Norris does not teach such access must be completely uninhibited, nor that such uninhibited access must be performable by the patient (¶ 14 of Norris, as cited by Applicant, already refers to the benefit that the clothing system provides to third-party caregivers specifically). Similarly, Young is still intended to provide medical access for caregivers (e.g. zippers 50 and 54). Thus, it is clear that the combination of Norris with the Young would not rise to the level of destroying the original operation of Norris, nor would it wholly prevent any and all “discrete access” to the upper torso and lower regions of the patient’s body. The example provided in MPEP 2143.01 VI illustrates how for a modification would require substantial reconstruction and redesign of the elements shown as well as the basic principle under which construction was designed to operate. Both Young and Norris are highly analogous in their field of endeavor, and provide access to at least third-party caregivers. Thus, the combination would not require a substantial redesign or change to the basic principle of operation of Norris (i.e. providing external access into medical garments).
Applicant further argues the combination does not teach “the bottom hem of the first upper layer not being connected to the second upper layer” as Young requires the 2 layers be joined together to form a pocket. However, the second upper layer appears attached to the first upper layer via a mid-torso seam (26). Similarly, the pocket (46) is above said mid-torso seam. This leaves the actual bottom hem of the first layer on attached to the second layer, and thus there would be no motivation to attach the bottom hem of Norris to the second layer as incorporated from Young.
Regarding claim 3, Applicant argues the shoulder area of Norris is not a “side”, and that one of ordinary skill in the art would understand a side never refers to the shoulder area of the garment, and would instead refer to either the right or left part of the wall or trunk of the body. However, being the first definition, or even the most common definition, does not render the term “side” beholden to only that singular definition/interpretation. Rather, claims must be interpreted under the broadest reasonable interpretation. As in the cited dictionary definitions provided by Applicant, side may also be defined as “a place, space, or direction with respect to a centerline of division”, “either surface of a thin object”, “a bounding line of a geometric figure”, etc. Thus, while Applicant’s interpretation of the term side is within the broadest reasonable interpretation, and may be the first interpretation drawn by one of ordinary skill in the art, other interpretations of “side” would not be strictly unreasonable. The term “side” is highly broad and has not been narrowed with respect to the opening (at least within claim 3) as it has with other elements of Applicant’s claim (e.g. front side). The openings of Norris would be reasonably considered to be on a shoulder side, top side, etc. of the garment, all of which are within the broadest reasonable interpretation of sides of the garment.
Applicant’s arguments regarding claim 15 on a lease the same grounds as claim 1, is similarly not persuasive.
Regarding new claim 22, the new language of the side seam required a new grounds of rejection as set forth below.
Applicant’s arguments regarding the dependent claims on at least the same grounds as independent claims 1, 15, and 22 are not persuasive as said claims remain rejected as set forth below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “closure element” in claim 4, and the “retention element” in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The first closure element and second closure mechanism are interpreted as the buttonhole and button, as recited in ¶ 30 of Applicant’s specification, as well as all known equivalents.
The retention element is interpreted as a strap, as recited in ¶ 41 of Applicant’s specification, as well as all known equivalents.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the bottom hem" in 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-14 and 21 are rejected via their dependency on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 9-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Norris (US 2023/0248603 A1), in view of Young (US 7,143,449 B2).
Regarding claim 1, Norris teaches an integrated garment (Fig. 2; Abstract) comprising:
a first upper layer (upper body garment 104), the first upper layer including at least one shoulder portion (shoulder coverings 120), the first upper layer further including an internal pocket formed on an internal front side of the first upper layer (Fig. 8 shows a reverse view of the internal front side, comprising pockets 196; ¶s 42-43), the internal pocket having a top opening (Fig. 8 shows the stitching being around the side and bottom edges, and the top being open);
a lower portion (leg portions 180); and
a waist portion (rise 170), the waist portion connected to the lower portion (¶ 39 indicates rise is also part of lower body garment 106 along with leg portions 180, below rise 170), the waist portion including at least one aperture formed on a front side of the waist portion (window 194 as shown in Fig. 6)
Norris does not explicitly teach a second upper layer, the second upper layer including at least one shoulder portion, where the bottom hem of the first upper layer is not connected to the second upper layer, and the waist portion connected to the second upper layer.
However, Young teaches a medical access garment (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a first upper layer (upper portion 18), and a second upper layer (liner 36), which comprises a shoulder portion (at connective shoulder portion 32), and the second upper layer is connected to the waist portion (seam 26), where the bottom hem of the first upper layer is not connected to the second upper layer (the liner 36 is connected to the upper portion 18 via bottom seam 26, which is far above the bottom hem of upper portion 18, at waist zipper 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris to comprise the liner of Young. Doing so would thus comprise a second upper layer including at least one shoulder portion and the waist portion connected to the second upper layer (i.e. where the leg portions begin in Norris), where the bottom hem of the first upper layer is not connected to the second upper layer. Doing so would be advantageous such that a user can withdraw their arms and access the internal elements while being covered by the first upper layer (Abstract of Young).
Limitations of the garment being an “ostomy” garment and the bottom hem of the first layer not being connected to the second upper layer “to allow a wearer of the integrated ostomy garment to access the internal pocket” are considered functional language as Applicant does not provide any ostomy specific structure. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Norris and Young has all the structure of the device as claimed. As such, it is capable of use with ostomy scenarios claimed.
Regarding claim 2, Young further teaches the first upper layer is connected to the second upper layer at a shoulder seam of the 2nd upper layer (shoulder portions 32; Col. 2, lines 21-25).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris to comprise the liner of Young. Doing so would thus comprise the first upper layer connected to the second upper layer at a shoulder seam of the second upper layer. Doing so would be advantageous such that a user can withdraw their arms and access the internal elements while being covered by the first upper layer (Abstract of Young).
Regarding claim 3, Norris further teaches a side opening (e.g. top side) by which the internal pocket may be accessed externally (fasteners 150 enable a side opening at shoulder coverings 120).
Regarding claim 6, Norris further teaches the first upper layer including a sleeve portion (sleeves 130).
Regarding claim 9, Norris further teaches the first upper layer includes a placket formed a neckline of the first upper layer and substantially in the middle of the front side of the first upper layer (neck portion 110; ¶ 33).
Regarding claim 10, Norris further teaches the waist portion further includes a retention element connected to an external front side of the waist portion (fasteners 150).
Regarding claim 11, Norris further teaches the waist portion is formed of a material having compression characteristics (¶ 39 describes that the waist portion may comprise an elastic band in the form of waste retainer 192).
Regarding claim 12, Norris further teaches the lower portion comprises at least one leg portion (each leg covering 180).
Regarding claim 13, Young further teaches the second upper layer further comprises a neckline of the second upper layer and substantially in the middle of a front side of the second upper layer (head access opening 44), but does not explicitly teach comprising a placket.
However, Norris teaches includes a neckline can be made in any variety of placket shapes so long as they allow a head to pass (¶ 33).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the neckline of Young with specifically a placket as taught by Norris since these structures perform the same function of allowing a head to pass. Simply substituting one neck configuration for another would yield the expected result of providing an opening through which a user can pass their head. See MPEP 2143.
Regarding claim 14, Norris further teaches the waist portion is formed of a material type that is different than a material type from which the first upper layer, the second upper layer, and the lower portion are formed (¶ 40 describes how the access covering 190 is uniformly constructed with rise 170 and is constructed of a separate material).
Regarding claim 15, Norris teaches an integrated garment (Fig. 2; Abstract) comprising:
a first upper layer (upper body garment 104), the first upper layer including at least one shoulder portion (shoulder coverings 120), the first upper layer further including an internal pocket formed on an internal front side of the first upper layer (Fig. 8 shows a reverse view of the internal front side, comprising pockets 196; ¶s 42-43), the internal pocket having a top opening (Fig. 8 shows the stitching being around the side and bottom edges, and the top being open),
the first upper layer further including a first side opening formed on the lefthand side of the first upper layer by which the internal pocket may be accessed externally to the garment, and a second side opening formed on the righthand side of the first upper layer by which the internal pocket may be accessed externally to the garment (fasteners 150 enable a side opening at shoulder coverings 120; Fig. 1 shows how the shoulder coverings are on both the right and left side; ¶ 33).
a lower portion (leg portions 180); and
a waist portion (rise 170), the waist portion connected to the lower portion (¶ 39 indicates rise is also part of lower body garment 106 along with leg portions 180, below rise 170), the waist portion including at least one aperture formed on a front side of the waist portion (window 194 as shown in Fig. 6),
wherein the waist portion is formed of a material having compression characteristics (¶ 39 describes that the waist portion may comprise an elastic band in the form of waste retainer 192) and the material from which the waist portion is formed is different in type than a material type from which the first upper layer, the second upper layer, and the lower portion are formed (¶ 40 describes how the access covering 190 is uniformly constructed with rise 170 and is constructed of a separate material).
Norris does not explicitly teach a second upper layer, the second upper layer including at least one shoulder portion and the waist portion connected to the second upper layer.
However, Young teaches a medical access garment (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a first upper layer (upper portion 18), and a second upper layer (liner 36), which comprises a shoulder portion (at connective shoulder portion 32), and the second upper layer is connected to the waist portion (seam 26), where the bottom hem of the first upper layer is not connected to the second upper layer (the liner 36 is connected to the upper portion 18 via bottom seam 26, which is far above the bottom hem of upper portion 18, at waist zipper 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris to comprise the liner of Young. Doing so would thus comprise a second upper layer including at least one shoulder portion and the waist portion substantially connected to the second upper layer (i.e. where the leg portions begin in Norris). Doing so would be advantageous such that a user can withdraw their arms and access the internal elements while being covered by the first upper layer (Abstract of Young).
Limitations of the garment being an “ostomy” garment and the bottom hem of the first layer not being connected to the second upper layer “to allow a wearer of the integrated ostomy garment to access the internal pocket” are considered functional language as Applicant does not provide any ostomy specific structure. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Norris and Young has all the structure of the device as claimed. As such, it is capable of use with ostomy scenarios.
Regarding claim 18, Norris further teaches the further includes to sleeve portions (pair of sleeves 130), and the lower portion further includes two leg portions (each leg covering 180).
Regarding claim 19, Norris further teaches the internal pocket has two top openings, one formed on the left-hand side of the internal pocket, and one formed on the right-hand side of the internal pocket (Fig. 8 shows two pockets on left and righthand sides of the device).
Regarding claim 20, Norris further teaches the first upper layer includes a placket formed a neckline of the first upper layer and substantially in the middle of the front side of the first upper layer (neck portion 110; ¶ 33).
Young further teaches the second upper layer further comprises a neckline of the second upper layer and substantially in the middle of a front side of the second upper layer (head access opening 44), but does not explicitly teach comprising a placket.
However, Norris teaches includes a neckline can be made in any variety of placket shapes so long as they allow a head to pass (¶ 33).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the neckline of Young with specifically a placket as taught by Norris since these structures perform the same function of allowing a head to pass. Simply substituting one neck configuration for another would yield the expected result of providing an opening through which a user can pass their head. See MPEP 2143.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Norris and Young, as applied to claim 1 above, and further in view of Stehli et al. (DE 202007014436 U1, IDS).
Regarding claim 4, the combination of Norris and Young do not explicitly teach the first upper layer including a first closure element located in a middle of an external front side of the front upper layer, and a second closure element located in the middle of a lower hemline of the first upper layer.
However, Stehli teaches a healthcare garment (Figs. 1-2; Abstract), thus being in the same field of endeavor, comprising a first upper layer (garment in Fig. 1) and a fastening apparatus consisting of a first closure element located substantially in the middle of an external front side of the first upper layer (upper pushbutton counterpart 6 and pushbutton 5) and a second closure element located substantially in the middle of a lower hemline (lower pushbutton counterpart 6 and pushbutton 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris and Young to comprise the fastening apparatus and flap of Stehli. Doing so would thus comprise the first upper layer including a fastening apparatus consisting of a first closure element located in a middle of an external front side of the front upper layer, and a second closure element located in the middle of a lower hemline of the first upper layer. Doing so would be advantageous to provide access into the garment (e.g. to the ostomy), through the first upper layer.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Norris, Young, and Stehli, as applied to claim 4 above, and further in view of Luckett (US 1,339,116 A).
Regarding claim 5, the combination of Norris, Young, and Stehli still do not explicitly teach one of the first closure element and the second closure element is a button and the other of the first closure element and the second closure element is a buttonhole.
In addressing the same problem as applicant, the problem being fastening of access flaps, Luckett teaches using a garment (Figs. 1-2) comprising a button and buttonhole (pointed end 15 and button 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the fastening apparatus of Norris, Young, and Stehli with the fastening apparatus comprising a button and corresponding buttonhole of Luckett since these structures perform the same function of reversibly connecting fabric portions. Simply substituting the fastening apparatus would achieve the expected result of analogous securing of the first upper layer portions. See MPEP 2143. Doing so would thus comprise one of the first closure element and the second closure element is a button and the other of the first closure element and the second closure element is a buttonhole.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Norris and Young, as applied to claim 1 above, and further in view of Klass (US 5,157,789 A).
Regarding claim 7, the combination of Norris and Young do not explicitly teach the internal pocket further includes a retention element internal to the internal pocket.
However, Klass teaches a hospital garment (garment 10 in Fig. 1; Abstract), thus being in the same field of endeavor, comprising a retention element internal to the internal pocket (hook and loop closure means 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pocket of Norris and Young to comprise the pocket retention element of Klass. Doing so would be advantageous to securely contain the pocket contents (Col. 3, lines 31-36 of Klass).
Regarding claim 8, the combination of Norris and Young do not explicitly teach the internal pocket further includes a retention element internal to the internal pocket.
However, Klass teaches a hospital garment (garment 10 in Fig. 1; Abstract), thus being in the same field of endeavor, comprising a removable pocket liner (bubble material liner 50; Col. 2, lines 26-33 describe how the liner is removable for cleaning).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pocket of Norris and Young to comprise the pocket liner of Klass. Doing so would be advantageous to provide pocket protection and easy removal for cleaning (Col. 2, lines 1-33 of Klass).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Norris and Young, as applied to claim 1 above, and further in view of Stehli.
Regarding claim 16, the combination of Norris and Young do not explicitly teach the first upper layer further including a first closure element located in a middle of an external front side of the front upper layer, and a second closure mechanism located in the middle of a lower hemline of the first upper layer.
However, Stehli teaches a healthcare garment (Figs. 1-2; Abstract), thus being in the same field of endeavor, comprising a first upper layer (garment in Fig. 1) and a first closure element located substantially in the middle of an external front side of the first upper layer (upper pushbutton counterpart 6 and pushbutton 5) and a second closure mechanism located substantially in the middle of a lower hemline (lower pushbutton counterpart 6 and pushbutton 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris and Young to comprise the fastening apparatus and flap of Stehli. Doing so would thus comprise the first upper layer including a first closure element located in a middle of an external front side of the front upper layer, and a second closure mechanism located in the middle of a lower hemline of the first upper layer. Doing so would be advantageous to provide access into the garment (e.g. to the ostomy), through the first upper layer.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Norris, Young, and Stehli, as applied to claim 16 above, and further in view of Luckett.
Regarding claim 17, the combination of Norris, Young, and Stehli still do not explicitly teach one of the first closure element and the second closure element is a button and the other of the first closure element and the second closure element is a buttonhole.
In addressing the same problem as applicant, the problem being fastening of access flaps, Luckett teaches using a garment (Figs. 1-2) comprising a button and buttonhole (pointed end 15 and button 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the fastening apparatus of Norris, Young, and Stehli with the fastening apparatus comprising a button and corresponding buttonhole of Luckett since these structures perform the same function of reversibly connecting fabric portions. Simply substituting the fastening apparatus would achieve the expected result of analogous securing of the first upper layer portions. See MPEP 2143. Doing so would thus comprise one of the first closure element and the second closure element is a button and the other of the first closure element and the second closure element is a buttonhole.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Norris and Young, as applied to claim 3 above, and further in view of Thomas (US 2019/0364992 A1).
Regarding claim 21, the combination of Norris and Young substantially disclose invention of claim 3. The combination does not explicitly teach the side opening is a long a side seam of the first upper layer.
However, Thomas teaches an easy access medical garment (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a number of openings on many sides of the garment, including a side opening that is along a side seam (opening to 2e; the seam can be seen in Fig. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris and Young comprise a side opening that is along a side seam of the first upper layer, as taught by Thomas. Doing so would be advantageous in providing easy access to a patient and improving comfort (¶ 90 of Thomas).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Norris in view of Young and Thomas.
Regarding claim 22, Norris teaches an integrated garment (Fig. 2; Abstract) comprising:
a first upper layer (upper body garment 104), the first upper layer including at least one shoulder portion (shoulder coverings 120), the first upper loop layer further including an internal pocket formed on an internal front side of the first upper layer (Fig. 8 shows a reverse view of the internal front side, comprising pockets 196; ¶s 42-43), the internal pocket having a top opening (Fig. 8 shows the stitching being around the side and bottom edges, and the top being open), the first upper layer further including a side opening by which the internal pocket may be accessed externally (fasteners 150 enable a side opening at shoulder coverings 120), the first upper layer including a side opening (e.g. top side) by which the internal pocket may be accessed externally (fasteners 150 enable a side opening at shoulder coverings 120)
a lower portion (leg portions 180); and
a waist portion (rise 170), the waist portion connected to the lower portion (¶ 39 indicates rise is also part of lower body garment 106 along with leg portions 180, below rise 170), the waist portion including at least one aperture formed on a front side of the waist portion (window 194 as shown in Fig. 6)
Norris does not explicitly teach a second upper layer, the second upper layer including at least one shoulder portion, the side opening is a long a side seam of the first upper layer, or the waist portion connected to the second upper layer.
Young teaches a medical access garment (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a first upper layer (upper portion 18), and a second upper layer (liner 36), which comprises a shoulder portion (at connective shoulder portion 32), and the second upper layer is connected to the waist portion (seam 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris to comprise the liner of Young. Doing so would thus comprise a second upper layer including at least one shoulder portion and the waist portion connected to the second upper layer (i.e. where the leg portions begin in Norris). Doing so would be advantageous such that a user can withdraw their arms and access the internal elements while being covered by the first upper layer (Abstract of Young).
The combination does not explicitly teach the side opening is a long a side seam of the first upper layer.
However, Thomas teaches an easy access medical garment (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a number of openings on many sides of the garment, including a side opening that is along a side seam (opening to 2e; the seam can be seen in Fig. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Norris and Young comprise a side opening that is along a side seam of the first upper layer, as taught by Thomas. Doing so would be advantageous in providing easy access to a patient and improving comfort (¶ 90 of Thomas).
Limitations of the garment being an “ostomy” garment considered functional language as Applicant does not provide any ostomy specific structure. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Norris, Young, and Thomas has all the structure of the device as claimed. As such, it is capable of use with ostomy scenarios claimed.
Regarding claim 23, Norris further teaches the first upper layer includes a placket formed a neckline of the first upper layer and substantially in the middle of the front side of the first upper layer (neck portion 110; ¶ 33).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781