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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 357, 359, 410 and 411 in figure 7 are not in the description.
Reference 323 in figure 8 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference number 34 mentioned in the specification is not the drawing.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the maximum circumference" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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, 5, 10, 11 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1).
Regarding claim 1, Fitzgerald et al disclose an enteral feeding bottle (70, fig 1), the enteral feeding bottle (70) comprising: a body (body of 70) comprising an exterior and an interior chamber (fig 2), the body further comprising an opening (72) to the interior chamber of the body (fig 2) and a base (fig 1, base of bottle 70), the body further comprising a flanged rim (76) along the opening (fig 2), a connecting ring (60) configured to interlock with the flanged rim of the body (fig 2 and para 0021); an enteral feeding device adaptor (10) configured to removably connect with the connecting ring (para 0021), the enteral feeding device adaptor (10) comprising an opening (56) configured to be removably connected with an enteral feeding device (80/90, para 0020), wherein a seal is formed between the flanged rim, the connecting ring, and the enteral feeding device adaptor (fig 2).
Fitzgerald et al fail to teach said body is formed from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer.
However, Wu discloses a feeding system comprising a container made from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer (para 0022).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Fitzgerald et al and incorporate the teachings of Wu to have the body of the bottle made from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer. This would provide the benefit of having a flexible bottle which is resiliently deformable meaning that the shape of the container can be non-plastically temporarily deformed under application of a force, the container returning to its original shape when the applied force is removed. This would help to easily connect said connecting ring to said bottle (see para 0022).
Regarding claim 2, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 1,
Fitzgerald et al fail to teach wherein the flanged rim defines an expanded state and a constricted state, wherein a minimum circumference of the connecting ring is smaller than a maximum circumference of the flanged rim in the expanded state.
However, in the modified bottle of Fitzgerald (see the rejection of claim 1 above), said bottle is made of flexible material, thus said flanged rim can be in expanded or in constricted state and the minimum circumference distance of ring 60 would be smaller than a maximum circumference distance of flange 76 when they are not connected to each other (see fig 2 of Fitzgerald et al).
Regarding claim 3, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 2, wherein the maximum circumference of the flanged rim in the constricted state is equal to or smaller than the maximum circumference of the connecting ring (see fig 2 of Fitzgerald et al: the maximum circumference distance of flange 76 is smaller than the maximum circumference distance of ring 60 when they are connected to each other).
Regarding claim 5, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 1,
Fitzgerald et al disclose wherein the body defines an angled portion (78), wherein the connecting ring is configured to surround the angled portion when the connecting ring is interlocked with the flanged rim (fig 2, section 64 surrounds part of angled portion 78).
Regarding claim 10, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 1,
Fitzgerald et al disclose wherein the body (70), the connecting ring (60), and the enteral feeding device adaptor (10) each comprise a cylinder (figs 1-4).
Regarding claim 11, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 1,
Fitzgerald et al disclose wherein the opening (56) of the enteral feeding device adaptor (10) comprises external threads (58), wherein the external threads of the enteral feeding device adaptor are configured to be interlocked with internal threads (89)of the enteral feeding device (fig 2 and para 0028).
Regarding claim 14, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 1,
Fitzgerald et al disclose wherein the flanged rim (76) forms a channel (79) between an upper section of the body of the enteral feeding bottle and the flanged rim, and the connecting ring (60) comprises a protrusion (64) extending in an axial direction and configured to be inserted within the channel (fig 2, col 4, lines 40-44).
Regarding claim 15, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 14,
Fitzgerald et al disclose wherein the flanged rim (76) is configured to be compressed between the protrusion (64) of the connecting ring (60) and an inner surface of the enteral feeding device adaptor (10) to form the seal (fig 2, rim 76 is between protrusion 64 and inner surface of member 20 of the adapter 10).
Regarding claim 16, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 14,
Fitzgerald et al disclose wherein the protrusion (64) extends about a circumference of the connecting ring (see fig 2).
Regarding claim 17, Fitzgerald et al disclose an enteral feeding system (fig 1) comprising: an enteral feeding bottle (70) comprising: a body (body of 70) comprising an exterior and an interior chamber (fig 2), the body further comprising an opening (72) to the interior chamber of the body (fig 2) and a base (base of 70), the body further comprising a flanged rim (76) along the opening (fig 2), a connecting ring (60) configured to interlock with the flanged rim of the body (fig 2 and para 0021), and an enteral feeding device adaptor (10) configured to removably connect with the connecting ring (para 0021), the enteral feeding device adaptor (10) comprising an opening (56) configured to be removably connected with an enteral feeding device (80/90, para 0020), wherein a seal is formed between the flanged rim, the connecting ring, and the enteral feeding device adaptor (figs 1-2); and an enteral feeding device (80/90) comprising: a nutrition adapter (80) comprising a coupling (86) configured to fluidly couple with the enteral feeding device adaptor (para 0028-29), a tube (90) fluidly coupled to the nutrition adapter (fig 2), and a feeding tube adapter (88) fluidly coupled to the tube, wherein the nutrition adapter, the tube, and the feeding tube adapter are formed as one piece (para 0028-29, fig 2).
Fitzgerald et al fail to teach said body is formed from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer.
However, Wu discloses a feeding system comprising a container made from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer (para 0022).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Fitzgerald et al and incorporate the teachings of Wu to have the body of the bottle made from a flexible material, wherein the flexible material comprises silicone or a thermoplastic elastomer. This would provide the benefit of having a flexible bottle which is resiliently deformable meaning that the shape of the container can be non-plastically temporarily deformed under application of a force, the container returning to its original shape when the applied force is removed. This would help to easily connect said connecting ring to the bottle (see para 0022).
Regarding claim 18, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 17,
Fitzgerald et al disclose wherein a minimum circumference of the connecting ring (60) is smaller than a maximum circumference of the flanged rim (fig 2, minimum distance between base 62 is smaller than a maximum circumference of the flanged rim 76).
Regarding claim 19, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 18,
Wu discloses wherein the flanged rim defines an expanded state and a constricted state (para 0022, since the bottle is made of flexible material, it is deformable in an expanded state and a constricted state), wherein the maximum circumference of the flanged rim in the constricted state is equal to or smaller than the maximum circumference of the flanged rim (it is inherent that the maximum circumference of the flanged rim is equal to or smaller than the maximum circumference of the flanged rim when said rim is deformed).
Regarding claim 20, Fitzgerald et al in view of Wu disclose the enteral feeding bottle of claim 17,
Fitzgerald et al disclose wherein the body defines an angled portion (78), wherein the connecting ring is configured to surround the angled portion when the connecting ring is interlocked with the flanged rim (fig 2, section 64 of ring 60 surrounds part of angled portion 78).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1) and further in view of Wood (US 5927549 A).
Regarding claim 4, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein a maximum circumference of the connecting ring is about equal to a maximum circumference of the body.
However, Wood teaches a bottle (12) comprising a connecting ring (28) wherein a maximum circumference of the connecting ring is about equal to a maximum circumference of the body (fig 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Fitzgerald et al in view of Wu and incorporate the teachings of Wood to have a maximum circumference of the connecting ring is about equal to a maximum circumference of the body. This would provide the benefit of having a conventional snap-fit bead for engaging said bottle to secure said ring to the neck of the bottle to have a smooth and continuous securement (col 4, lines 35-40).
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1 and further in view of Meier et al (US 6183465 B1).
Regarding claim 6, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein the connecting ring comprises external threads and the enteral feeding device adaptor comprises internal threads, wherein the external threads of the connecting ring are configured to interlock with the internal threads of the enteral feeding device adaptor.
However, Meier et al disclose a feeding system (fig 1) comprising a connecting ring (16) and a feeding device adaptor (12/14) wherein the connecting ring comprises threads (66) and the enteral feeding device adaptor comprises threads (34), wherein the threads of the connecting ring are configured to interlock with the threads of the enteral feeding device adaptor (figs 1-6 and col 7 lines 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the locking connection between said connecting ring and said adaptor of Fitzgerald et al to have thread connection as taught by Meier et al since there exist a variety of other connective arrangements that may be utilized to connect two components. Threaded connection is known to have superior mechanical strength and secure mating.
Regarding claim 12, Fitzgerald et al in view of Wu disclose the limitations of claim 1 and further teach the enteral feeding device adaptor (10) comprises a rigid material (para 0021) but fail to teach wherein the connecting ring comprises a rigid material.
However, Meier et al disclose a feeding system (fig 1) comprising a connecting ring (16) and a feeding device adaptor (12/14) wherein the connecting ring (16) comprises a rigid material (col 7, lines 48-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the connecting ring to comprise a rigid material. This would provide the benefit of having a rigid material to ensure rigid retaining (col 7, lines 48-52).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1 and further in view of Brandenburger et al (US 20180296438 A1).
Regarding claim 7, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein the enteral feeding device adaptor comprises a tethered cap.
However, Brandenburger et al disclose a feeding system (fig 2A) comprising an enteral feeding device (15) wherein the enteral feeding device adaptor comprises a tethered cap (16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adaptor of Fitzgerald et al and incorporate the teachings of Brandenburger et al to have the enteral feeding device adaptor comprises a tethered cap. This would provide the benefit of having a cap attached to the adaptor to cover said adapter when the enteral feeding bottle is not being used (para 0092).
Regarding claim 8, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein the base of the body comprises a hole arranged about an axis, wherein the axis of the hole is approximately perpendicular to an axis about which the opening of the body is arranged.
However, Brandenburger et al disclose a feeding system (fig 2A) comprising a base (fig 3A wherein the base of the body comprises a hole (17) arranged about an axis, wherein the axis of the hole is approximately perpendicular to an axis about which the opening of the body is arranged (fig 3A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bottle of Fitzgerald et al and incorporate the teachings of Brandenburger et al to have the base of the body comprises a hole arranged about an axis, wherein the axis of the hole is approximately perpendicular to an axis about which the opening of the body is arranged. This would provide the benefit of hanging said bottle into a hook to allow solution to flow out by means of gravitational force (para 0095).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1 and further in view of Rohrig (US 5339971 A).
Regarding claim 9, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein the base of the body comprises a lipped bottom configured to provide a vacuum lock when placed on a surface.
However, Rohrig discloses a feeding bottle (1) comprises a base (2) wherein the base of the body comprises a lipped bottom (6) configured to provide a vacuum lock when placed on a surface.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bottle of Fitzgerald et al to have the base of the body comprises a lipped bottom configured to provide a vacuum lock when placed on a surface as taught by Rohrig. This would provide the benefit of having said bottle to be able to stand when it not in use to prevent spill (col 3, lines 33-37).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al (EP 2417958 A1) in view of Wu (US 20220339074 A1 and further in view of Groot et al (US 20180251254 A1).
Regarding claim 13, Fitzgerald et al in view of Wu disclose the limitations of claim 1 but fail to teach wherein the body of the enteral feeding bottle is compressible in a radial direction and not compressible in an axial direction.
However, Groot et al disclose an enteral feeding bottle (1) wherein the body of the enteral feeding bottle is compressible in a radial direction and not compressible in an axial direction (para 0016).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bottle of Fitzgerald et al to and incorporating the teachings of Groot et al to have the body of the enteral feeding bottle compressible in a radial direction and not compressible in an axial direction. This would provide the benefit of maintaining the bottle straight to allow contents of bottle to smoothly pass from the bottle to feeding device by preventing buckling or folding (para 0040-0042).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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