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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/2/2026 has been entered.
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 Sepetka et al. (US 5308342 hereinafter “Sepetka”).
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) whereby said tube body (12) provides enhanced resistance to both (a) kinking during placement and use as well as (b) clogging with particulate matter (this limitation (both (a) and (b) are considered functional limitations. Since Blanchard meets the structural limitations of a tube having an outer diameter and a thickness (which all tube bodies necessarily have) Blanchard meets the functional limitations of providing resistance to kinking and clogging).
Blanchard does not specify the tube body characterized by an equation OD^x/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.
However, Blanchard does teach that the diameter and thickness of the tube may vary (see [0072-0073] teaching how the outer diameter could swell and outer wall thickness could vary).
As seen in Blanchard [0072-0073], the outer diameter could swell and outer wall thickness could vary based on the desired size of devices used with the tube and based on the materials used for manufacturing the tube. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the tube body of Blanchard Fig 4 to have an outer diameter and wall thickness that would result in tube body characterized by an equation OD^x/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,
as it involves only adjusting the dimension of a component disclosed to require adjustment (the outer diameter and wall thickness). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Blanchard by making the tube body characterized by an equation OD^x/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
as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Sepetka teaches (Col 2 line 65- Col 3 line 4) a tube body (18) with an outer diameter in the range of 0.75 – 2.0 mm, and a wall thickness of 0.08 – 0.16 mm. If one were to use the lower end of these ranges, OD = .75mm and t = 0.08 mm and have X=1.25, then C would be 8.72.
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 0.75 mm and 0.08 mm respectively as taught by Sepetka. 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.
PNG
media_image1.png
152
631
media_image1.png
Greyscale
Annotated Fig 4 (Blanchard)
Regarding Claim 80, the combination of Blanchard and Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka 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 Sepetka (US 5308342) as applied to claim 79 above, and further in view of Fields (US Patent 5017193).
Regarding Claim 90, the combination of Blanchard and Sepetka 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 4/2/2026.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights