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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 79-86, and 89-92 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 79-86 and 89-92 are rejected under 35USC112(a) enablement. Claims 79 and 88 state a constant ‘X’ is equal to 1.25, 1.5 or 1.75, without providing any support or description on what this constant represents. The constant ‘X’ is used in an equation/formula recited in line 2 of Claim 79, which defines the tube body. However, due to the lack of disclosure on what the constant ‘X’ represents, it is unclear why the constant ‘X’ must be the values 1.25, 1.5 or 1.75.
The disclosure describes the equation in paragraph [0069]. Paragraph [0069] explains that ‘OD’ is an outer diameter of the tube, ‘t’ is the wall thickness of the tube. However, paragraph [0069] does not explain what the constant ‘X’ represents. The only disclosure is that ‘X’ equals 1.25, 1.5 or 1.75. Therefore, it is not clear how to make the tube body of the enteral feeding tube characterized by the equation/formula outlined in claim 79, because one having ordinary skill in the art would not know what the constant ‘X’ represents to get the claimed tube body of the enteral feeding tube or how to make the claimed tube body of the enteral feeding tube characterized by the equation in Claim 79, where ‘X’ equals 1.25, 1.5 or 1.75. One of ordinary skill in the art would not know how to differentiate a tube body with a constant X = 1.25, compared to a tube body with a constant X = 1.5 or a tube body with a constant X = 1.75. Similarly, one of ordinary skill in the art would not know how to make a tube body that meets the limitation of a constant X = 1.25 compared to a constant X = 1.5 or a constant X = 1.75.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what structure/characteristic the constant ‘X’ is related to in terms of the design of the tube body, one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine what the constant ‘X’ represents, it is unclear why the variable ‘X’ must be the values 1.25, 1.5 or 1.75, and therefore the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention, one would have to experiment unduly to reach the claimed result a tube body characterized by the constant ‘X’ which is selected from the values 1.25, 1.5 or 1.75, and thus the invention is not enabled.
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 79-86, 89-92 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 79 recites ‘X’ is equal to 1.25, 1.5 or 1.75, without providing any support or description on what this constant represents. The constant ‘X’ is used in an equation/formula recited in line 2 of Claim 79, which defines the tube body. However, due to the lack of disclosure on what the constant ‘X’ represents, it is unclear why the constant ‘X’ must be the values 1.25, 1.5 or 1.75, or how one would derive this constant ‘X’ based on the structural design of the tube body.
Claims 80-86 and 89-92 are rejected due to their dependency on claim 79.
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.
Claim(s) 79-86, 89 and 91-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard et al. (US Patent Pub. 20120041419 hereinafter “Blanchard”) in view of Sacks et al. (US 4758219 hereinafter “Sacks”).
Regarding Claim 79, Blanchard teaches (Fig 1 and 4) An enteral feeding tube, comprising:
a tube body (12) includes a proximal end portion (20) extending from a proximal end (12A) to an intermediate portion (35) and a distal end portion (30) extending from the intermediate portion (35) to a distal (12B), patient insertion end (See [0037] defining distal as the end near patient and see [0041] teaching 12B is distal end), and wherein (a) an outer diameter of the distal end portion (30) at the distal, patient insertion end is greater than an out diameter of the proximal end portion (20; see annotated Fig 4) and (b) the intermediate portion (35) defines a lumen having an inner diameter and an outer diameter each increasing toward the distal end portion (See Fig 4).
Blanchard does not specify the tube body characterized by an equation ODX/t= C where
OD = outer diameter of the tube body,
t = wall thickness of the tube body,
C is a constant having a value between 6.0 and 18.0 and X is a constant having a value of 1.25, 1.5 or 1.75.
Sacks teaches (Fig 1) an enteral feeding tube, comprising:
a tube body (32) characterized by an equation OD^x / t = C where
OD = outer diameter of the tube body (Col 4 lines 6-8 teaches that outer diameter is 0.19 inches),
t = wall thickness of the tube body (Col 4 line 10 teaches wall thickness is 0.010 inches),
C is a constant having a value between 6.0 and 18.0 and X = 1.25, 1.5 or 1.75 (See 112 rejections above; Based on the remarks filed 11/6/2025, it is interpreted that any of the following values X are a constant that can be used for the equation, as such, when X is 1.25 the resulting C is 12.5, when X is 1.5, the resulting C is 8.28; both these C values are between 6.0 and 18.0).
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 outer diameter and thickness of the tube body of Blanchard such that it is 0.19 inches and 0.010 inches respectively as taught by Sacks. One of ordinary skill in the art would recognize that varying the size/dimensions of the tube body for the desired use would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Furthermore, these are known dimensions for tube bodies in the field of art.
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Annotated Fig 4 (Blanchard)
Regarding Claim 80, the combination of Blanchard and Sacks teaches all elements of claim 79 as described above. The combination does not specify the enteral feeding tube wherein the tube body has a total length L, the proximal end portion and the distal end portion each have a length of about .0071L to .0526L and the intermediate portion has a length of about .895L to .986L.
However, Blanchard does teach in [0051] and [0054] that the length of the different sections of the tube could be varied as desired to suite the uses of the desired application. The instant disclosure describes the parameter of wherein the tube body has a total length L, the proximal end portion and the distal end portion each have a length of about .0071L to .0526L and the intermediate portion has a length of about .895L to .986L as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system (See instant application paragraphs [0064-0066] teaching multiple ranges for the lengths of the tube sections). As such, parameters such as wherein the tube body has a total length L, the proximal end portion and the distal end portion each have a length of about .0071L to .0526L and the intermediate portion has a length of about .895L to .986L are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of wherein the tube body has a total length L, the proximal end portion and the distal end portion each have a length of about .0071L to .0526L and the intermediate portion has a length of about .895L to .986L would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 81, the combination of Blanchard and Sacks teaches all elements of claim 79 as described above. The combination does not specify the enteral feeding tube wherein the intermediate portion has a taper ratio selected from the group consisting of between about 0.004 and 0.00015, between about .004 and 0.0006, and between about 0.0015 and 0.00015, and between about 0.00129 and 0.000516.
However, Blanchard does teach in [0051 -0052] that the length, cross sectional sizes and relative size differences between the different sections of the tube could be varied as desired to suite the uses of the desired application. The instant disclosure describes the parameter of the intermediate portion has a taper ratio selected from the group consisting of between about 0.004 and 0.00015, between about .004 and 0.0006, and between about 0.0015 and 0.00015, and between about 0.00129 and 0.000516 as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system (See instant application paragraph [0037]). As such, parameters such as the intermediate portion has a taper ratio selected from the group consisting of between about 0.004 and 0.00015, between about .004 and 0.0006, and between about 0.0015 and 0.00015, and between about 0.00129 and 0.000516 are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the intermediate portion has a taper ratio selected from the group consisting of between about 0.004 and 0.00015, between about .004 and 0.0006, and between about 0.0015 and 0.00015, and between about 0.00129 and 0.000516 would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 82, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 79, wherein the proximal end portion (Blanchard Fig 4, 20) has a constant internal diameter A (See annotated Fig 4 of Blanchard).
Regarding Claim 83, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 82, wherein the distal end portion (Blanchard Fig 4, 30) has a constant internal diameter B where A < B (See annotated Fig 4 of Blanchard, diameter B is greater than diameter A).
Regarding Claim 84, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 83, wherein A is between about 1.25 mm and 2.27 mm (See Blanchard [0052] teaching possible diameters of tube 12 including 0.063 inches (1.60 mm) and 0.070 inches (1.85mm); as [0052] teaches various sizes could be used, it is interpreted that the diameter A of Fig 4 could be between 1.25mm and 2.27 mm as these are known diameter values for a medical tube).
Regarding Claim 85, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 84, wherein B is between about 1.72 mm and 2.75 mm (See Blanchard [0052] teaching possible diameters of tube 12 including 0.095 inches (2.41mm) and 0.070 inches (1.85mm); as [0052] teaches various sizes could be used, it is interpreted that the diameter B of Fig 4 could be between 1.72mm and 2.75 mm as these are known diameter values for a medical tube).
Regarding Claim 86, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 83, wherein the constant internal diameter A (see annotated Blanchard Fig 4) of the proximal end portion and the constant internal diameter B (see annotated Blanchard Fig 4) of the distal end portion are selected from the group consisting of A is about 2.27 mm and B is about 2.75 mm, A is about 1.89 mm and B is about 2.41 mm, and A is about 1.25 mm and B is about 1.72 mm (See Blanchard [0052] teaching possible diameters of tube 12 including 0.095 inches (2.41mm), 0.063 inches (1.60 mm) and 0.070 inches (1.85mm); as [0052] teaches various sizes could be used, it is interpreted that the diameter A of Fig 4 could be between 1.25mm and 2.27 mm, and the diameter B of Fig 4 could be between 1.72mm and 2.75 mm as these are known diameter values for a medical tube).
Regarding Claim 89, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 79, wherein the tube body has a diameter selected from the group consisting of 5-6 French (FR), 8-10 FR ad 10-12 FR (See Blanchard [0052] teaching various French sizes between 2.5-8).
Regarding Claim 91, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 79, wherein the tube body has a proximal end portion outer diameter of between about 1.58 mm and 3.25 mm (See Blanchard [0052] teaching possible diameters of tube 12 including 0.095 inches (2.41mm), 0.063 inches (1.60 mm) and 0.070 inches (1.85mm); as [0052] teaches various sizes could be used, it is interpreted that the diameter of the proximal portion of Fig 4 could be between 1.58 mm and 3.25 mm as these are known diameter values for a medical tube) and a proximal end portion inner diameter of between about 1.25 mm and 2.27 mm (See Blanchard [0052] teaching possible wall thickness values 0.011, 0.0070 and 0.0080 inches, which would result in an inner diameter of 0.084 inches (2.13 mm), 0.056 inches (1.42 mm) or 0.062 inches (1.57 mm); as [0052] teaches various sizes could be used, it is interpreted that the inner diameter of the proximal portion of Fig 4 could be between 1.25 mm and 2.27 mm as these are known diameter values for a medical tube).
Regarding Claim 92, the combination of Blanchard and Sacks teaches the enteral feeding tube of claim 79, wherein the tube body has a distal end portion outer diameter of between about 2.30 mm and 4.17 mm (See Blanchard [0052] teaching possible diameters of tube 12 including 0.095 inches (2.41mm) and a distal end portion inner diameter of between about 1.72 mm and 2.75 mm (See Blanchard [0052] teaching a possible wall thickness values 0.011 inches, which would result in an inner diameter of 0.084 inches (2.13 mm); as [0052] teaches various sizes could be used, it is interpreted that the outer diameter of the distal portion of Fig 4 could be between 2.30 mm and 4.17 mm and the inner diameter of the distal portion of Fig 4 could be between 1.72 mm and 2.75 mm as these are known diameter values for a medical tube).
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US Patent Pub. 20120041419) in view of Sacks (US 4758219)as applied to claim 79 above, and further in view of Fields (US Patent 5017193).
Regarding Claim 90, the combination of Blanchard and Sacks teaches all elements of claim 79 as described above. Blanchard does not specify the enteral feeding tube wherein the tube body is made from a material having a Shore hardness of between about 70-90A.
Fields teaches (Col 4 lines 58-60) a tube (12) having a durometer of approximately 80 Shore A.
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 material of the tube body of Blanchard such that it has a Shore hardness of between about 70-90A as taught by Fields. One of ordinary skill in the art would have been motivated to do so as this is a known material for feeding tubes (Fields Col 4 lines 58-60). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Response to Arguments
Applicant’s arguments with respect to claim(s) 79 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 11/6/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rotella et al. (US Patent 20120089128) teaches a feeding tube with a larger diameter distal end.
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783