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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 04/09/2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/09/2026.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-14 are rejected under 35 U.S.C. 101 as claiming the same invention as that of Claims 1-13 of prior U.S. Patent No. 11,801,204 (Finck). This is a statutory double patenting rejection.
As to Claim 1, Finck teaches a nasogastric device, comprising: a first flexible tube having a distal end configured to be threaded through the nose of a patient, down the esophagus and into the stomach; a second flexible tube disposed adjacent to the first tube having a distal end proximate to the distal end of said first flexible tube, the distal end of said second tube configured to terminate inside the esophagus; an inflatable balloon configured around said first and second flexible tubes, the inflatable balloon disposed proximal to the distal end of the first and second flexible tubes; a third flexible tube in fluid communication with said balloon configured to inflate said inflatable balloon; and a fourth flexible tube having a distal end portion communicating with an exterior portion of said inflatable balloon, the fourth tube configured to transport suspensions or solutions of materials, such as therapeutic molecules into a space exterior to said inflatable balloon. (Claim 1, Lines 7-24)
As to Claim 2, Finck teaches a nasogastric device in accordance with claim 1, wherein at least a portion of the distal end of said first flexible tube includes perforations configured to allow material injected into said tube to exit freely into the stomach. (Claim 10)
As to Claim 3, Finck teaches a nasogastric device in accordance with claim 2, wherein said perforations have a length of between 1 and 8 millimeters. (Claim 11)
As to Claim 4, Finck teaches a nasogastric device in accordance with claim 1, wherein at least the last 5 centimeters of the distal end of said first flexible tube includes perforations. (Claim 2)
As to Claim 5, Finck teaches a nasogastric device in accordance with claim 1, wherein the distal end of said second flexible tube extends between 1 and 10 centimeters below the distal end of said first inflatable balloon. (Claim 8)
As to Claim 6, Finck teaches a nasogastric device in accordance with claim 5, wherein at least a portion of said distal end includes perforations that have a length of between 1 and 3 millimeters. (Claim 9)
As to Claim 7, Finck teaches a nasogastric device in accordance with claim 1, wherein said inflatable balloon has an initial radius of between about 5 millimeters and 2 centimeters. (Claim 3)
As to Claim 8, Finck teaches a nasogastric device in accordance with claim 1, wherein said inflatable balloon has an initial length of between about 0.5 and 30 centimeters. (Claim 4)
As to Claim 9, Finck teaches a nasogastric device in accordance with claim 1, further comprising an elastomeric sleeve at least partially surrounding said inflatable balloon, elastomeric sleeve in fluid communication with said fourth tube, the elastomeric sleeve including perforations configured to allow release of said therapeutic molecules there through. (Claim 1, Lines 24-28)
As to Claim 10, Finck teaches a nasogastric device in accordance with claim 2, wherein said perforations are configured as semicircular patterns. (Claim 12)
As to Claim 11, Finck teaches a 11. A nasogastric device in accordance with claim 10, wherein said perforations are configured having lengths between about 0.5 micrometers and 25 millimeters. (Claim 13)
As to Claim 12, Finck teaches a nasogastric device in accordance with claim 9, wherein elastomeric sleeve is configured to closely surround at least a portion of the inflatable balloon such that inflation of the inflatable balloon pushes therapeutic molecules contained within elastomeric sleeve through the perforations of elastomeric sleeve. (Claim 5)
As to Claim 13, Finck teaches a nasogastric device in accordance with claim 9, further comprising at least one radiopaque marker provided near a distal portion of an element of said nasogastric device. (Claim 6)
As to Claim 14, Finck teaches a nasogastric device in accordance with claim 1, further comprising ports configured at the proximal ends of each of said four tubes. (Claim 7)
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
a distal portion of an element of said nasogastric device
No new matter should be entered.
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: 130.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 2-14 are objected to because of the following informalities.
The preamble of each of the dependent claims should read –The[[A]] nasogastric device in accordance with claim…--
Claim 9 should read --The[[A]] nasogastric device in accordance with claim 1, further comprising an elastomeric sleeve at least partially surrounding said inflatable balloon, said elastomeric sleeve in fluid communication with said fourth tube, the elastomeric sleeve including perforations configured to allow a release of said therapeutic molecules there through.—
Claim 14 should read --The[[A]] nasogastric device in accordance with claim 1, further comprising ports configured at
Appropriate correction is required.
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 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.
As to Claim 1, the limitation “a first flexible tube having a distal end configured to be threaded through the nose of a patient, down the esophagus and into the stomach”, in Lines 2-3, is indefinite. It is not clear how to interpret the phrase “threaded through”, and the phrase does not appear to be a term of the art. One of ordinary skill in the art would interpret the phrase as though helical threads are being used to insert the first tube. However, no threads have been disclosed, and it is not clear where the threads would be placed. For the purpose of examination, the phrase will be interpreted as “inserted through”.
The terms “the nose”, “the esophagus”, and “the stomach” lack antecedent basis.
The limitation “the distal end of said second tube configured to terminate inside the esophagus”, in Lines 5-6, is indefinite. The limitation requires context. For instance, prior to inserting the claimed device into the patient, the second tube distal end will not terminate inside the esophagus. As such, it is not clear how the second tube distal end terminates inside the esophagus.
The limitation “the inflatable balloon disposed proximal to the distal end of the first and second flexible tubes”, in Lines 7-8, is indefinite. The limitation only defines one distal end of the first and second flexible tubes. As such, it is not clear which one of the distal ends is being claimed. For the purpose of examination, the limitation will be interpreted as the inflatable balloon disposed proximal to the distal end of each of the first and second flexible tubes.
The limitation “the fourth tube configured to transport suspensions or solutions of materials, such as therapeutic molecules into a space exterior to said inflatable balloon”, in Lines 12-14, is indefinite. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As to Claim 2, the term “said tube”, in Line 3, is indefinite. Multiple tubes have been defined. As such, it is not clear which tube is being referred to in Line 3. For the purpose of examination, the tube referred to in Line 3 will be interpreted as the first tube.
As to Claim 4, the limitation “at least the last 5 centimeters of the distal end of said first flexible tube includes perforations”, is indefinite.
The phrase “the last 5 centimeters” lacks antecedent basis.
The phrase is a relative term which renders the claim indefinite. The phrase is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase requires a start and end point. For example, if the measurement starts at the distal end, the last 5 centimeter will be different than if the measurement starts at the proximal end. Since the boundary of the distal end also has not been defined, it is not clear where the measurement begins or ends.
As to Claim 6, the limitation “at least a portion of said distal end includes perforations that have a length of between 1 and 3 millimeters”, is indefinite. Multiple distal ends have been defined. As such, it is not clear which distal end is being referred to in Claim 6. For the purpose of examination, the distal end of Claim 6 will be interpreted as the distal end of the first tube.
As to Claim 7, the limitation “said inflatable balloon has an initial radius of between about 5 millimeters and 2 centimeters”, is indefinite.
It is not clear at what point the balloon has an initial radius. For example, the initial radius may be prior to inflation, or the initial radius may be after partial inflation, or the initial radius may be at full inflation. Additionally, it is not clear which portion of the balloon has the initial radius at any given point during operation.
As to Claim 12, the limitation “elastomeric sleeve is configured to closely surround at least a portion of the inflatable balloon such that inflation of the inflatable balloon pushes therapeutic molecules contained within elastomeric sleeve through the perforations of elastomeric sleeve” is indefinite.
The phrase “closely surround” is a relative term which renders the claim indefinite. The phrase is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 9 states the elastomeric sleeve at least partially surrounds the inflatable balloon, which inherently involves a portion of the balloon. As such, it is not clear if the portion of the inflatable balloon which is surrounded in Claim 9 is the same portion of the inflatable balloon which is surrounded in Claim 12. For the purpose of examination, the two portions will be interpreted as the same portion.
The term “elastomeric sleeve”, in Lines 1, 3 & 4, should read –the elastomeric sleeve.
The term “therapeutic molecules”, in Line 3, should read –the therapeutic molecules.
As to Claim 13, the limitation “at least one radiopaque marker provided near a distal portion of an element of said nasogastric device” is indefinite. It is not clear which structure the term “an element” is referring to. The use of the term allows for undefined structures to be in integrated into the claimed invention. Since those structures have not been previously defined, it is not clear which structures are or are not part of the claimed invention. Additionally, multiple distal portions have been previously defined, so it is not clear if the distal portion of the unknown element is the same distal portion of any of the previously claimed distal ends/portions.
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.
Claims 1-2, 4-5, 7-9 & 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (U.S. PGPub 2015/0005743), in view of Eaton (U.S. PGPub 2012/0143054).
As to Claim 1, McCullough teaches a nasogastric (the intent to use the claimed device as a nasogastric device is considered intended use; see end of paragraph for clarification) device (the device shown in Figure 1, using the “specialty wire” 140, shown in Figure 10; see Paragraph 0036), comprising:
a first flexible (Paragraphs 0018/0036) tube (32/140) having a distal end (150; see Figure 10) configured to be (although McCullough does not explicitly state the device is used for nasogastric means, one of ordinary skill in the art would conclude the device may be used in such a manner; see end of paragraph for clarification) threaded through the nose of a patient (intended use), down the esophagus (intended use) and into the stomach (intended use);
a second flexible (Paragraph 0018) tube (the portion of tube 14 creating lumen 28) disposed adjacent to (as shown in Figure 1) the first tube (32/140) having a distal end (30) proximate to (as shown in Figure 1) the distal end (150) of said first flexible tube (32/140), the distal end (30) of said second tube (the portion of tube 14 creating lumen 28) configured to terminate inside the esophagus (this limitation is considered intended use; one of ordinary skill in the art would conclude whoever is inserting the claimed device is capable of placing the second tube distal end within an esophagus depending on how the claimed device is being used);
an inflatable (Paragraph 0024) balloon (22) configured around (as shown in Figure 1) said first (32/140) and second (the portion of tube 14 creating lumen 28) flexible tubes, the inflatable balloon (22) disposed proximal to (as shown in Figure 1) the distal end (150/30) of the first (32/140) and second (the portion of tube 14 creating lumen 28) flexible tubes;
a third flexible (Paragraph 0018) tube (the portion of tube 14 creating lumen 20) in fluid communication with (Paragraph 0024) said balloon (22) configured to inflate (Paragraph 0024) said inflatable balloon (22); and
transporting (Paragraphs 0021/0023) suspensions or solutions of materials (the therapeutic agents described in Paragraph 0023), such as therapeutic molecules (the therapeutic agents described in Paragraph 0023) into (Paragraph 0021) a space (34) exterior to (as shown in Figure 1; Paragraph 0021) said inflatable balloon (22).
The intention to use the claimed device as a nasogastric tube is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, one of ordinary skill in the art would conclude the McCullough device may be used as a nasogastric tube, especially since the device has very similar structure to the claimed invention.
McCullough does not teach the use of a fourth flexible tube to transport the therapeutic molecules, so does not explicitly teach a fourth flexible tube having a distal end portion communicating with an exterior portion of said inflatable balloon, the fourth tube configured to transport suspensions or solutions of materials, such as therapeutic molecules into a space exterior to said inflatable balloon.
Eaton describes a similar device, and teaches a fourth flexible (Paragraph 0042) tube (212) having a distal end portion (212B) communicating with (Paragraph 0047) an exterior portion of (as shown in Figure 3A) said inflatable balloon (44), the fourth tube (212) configured to transport suspensions or solutions of materials, such as therapeutic molecules (the fluid and carrier described in Paragraphs 0041/0092) into a space (242) exterior to (as shown in Figure 3A) said inflatable balloon (42).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the fourth tube, as taught by Eaton, in the device, as taught by McCullough, to have greater control of the therapeutic solution directed into the space exterior to the inflatable balloon. Additionally, the use of tubes directly into the space exterior to the inflatable balloon is well-known, and yields predictable results, i.e., delivers fluid directly to the space.
As to Claim 2, McCullough, as modified, teaches all the limitations of Claim 1, and continues to teach at least a portion of the distal end (McCullough 150) of said first flexible tube (McCullough 32/140) includes (McCullough Paragraph 0036) perforations (McCullough 148) configured to allow material (the liquid/therapeutic agent described in McCullough Paragraph 0036) injected into (via McCullough 146, as described in McCullough Paragraph 0036) said tube (McCullough 32/140) to exit freely into the stomach (intended use; one of ordinary skill in the art would conclude any material exiting McCullough perforations 148 would be free to move into a stomach if the distal end of the first tube was placed within a stomach).
As to Claim 4, McCullough, as modified, teaches all the limitations of Claim 1, and continues to teach at least the last 5 centimeters (see end of paragraph for clarification) of the distal end (McCullough 150) of said first flexible tube (McCullough 32/140) includes perforations (McCullough 148). When referencing McCollough Figure 10 below, one of ordinary skill in the art would determine the last 5 centimeters of the distal end of the first flexible tube includes the perforation 148 when measured from left to right, since the perforations 148 end at the end of the last 5 centimeters.
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McCollough Figure 10, Modified by Examiner
As to Claim 5, McCullough, as modified, teaches all the limitations of Claim 1, but is silent on the length of the distal end below the first inflatable balloon, so does not explicitly teach the distal end of said second flexible tube extends between 1 and 10 centimeters below the distal end of said first inflatable balloon.
Eaton continues to teach elastomeric sleeve 42 may have a length which can range from 15 mm to 250 mm (1.5 cm to 25 cm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric sleeve and inflatable balloon length, as McCollough, the same length, as taught by Eaton, to make the sleeve/balloon an appropriate size for use (Paragraph 0070).
When referencing the extension length (see Figure McCollough Figure 1 below) of the distal end (McCollough 30) of the second flexible tube (the portion of McCollough tube 14 creating McCollough lumen 28) in combination with the elastomeric sleeve length, one of ordinary skill in the art would conclude the extension length is approximately in a range between 1 and 10 centimeters.
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McCollough Figure 1, Modified by Examiner
It would have been obvious to one of ordinary skill in the art to modify the distal end of the second tub extension length below the balloon to be between about 1 and 10 centimeters, since it has been held “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ 2d 1934 (Fed. Cir. 1990).
As to Claim 7, McCullough, as modified, teaches all the limitations of Claim 1, and continues to teach said inflatable balloon (McCullough 22) has an initial radius of between about 5 millimeters and 2 centimeters. McCollough Figure 1 shows inflatable balloon 22 in contact with catheter 30. Eaton describes a typical catheter size as being about 4 mm, which is about 5 mm. As such, one of ordinary skill in the art would conclude, as evidenced by Eaton, the diameter of the portion of the McCollough balloon 22 contacting the McCollough catheter 30 is always about 5 mm.
As to Claim 8, McCullough, as modified, teaches all the limitations of Claim 1, but is silent on the length of the inflatable balloon, so does not explicitly teach said inflatable balloon has an initial length of between about 0.5 and 30 centimeters.
Eaton continues to teach elastomeric sleeve 42 may have a length which can range from 15 mm to 250 mm (1.5 cm to 25 cm). When referencing Eaton Figure 3A, one of ordinary skill in the art would conclude the inflatable balloon is only slightly smaller than the elastomeric sleeve.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric sleeve and inflatable balloon length, as McCollough, the same length, as taught by Eaton, to make the sleeve/balloon an appropriate size for use (Paragraph 0070).
It would have been obvious to one of ordinary skill in the art to modify the elastomeric sleeve and inflatable balloon length to be between about 0.5 and 30 centimeters, since it has been held “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ 2d 1934 (Fed. Cir. 1990).
As to Claim 9, McCullough, as modified, teaches all the limitations of Claim 1, and continues to teach an elastomeric sleeve (McCullough 34) at least partially surrounding (as shown in McCullough Figure 1) said inflatable balloon (McCullough 22), elastomeric sleeve (McCullough 34) in fluid communication with (Eaton Paragraph 0047; McCullough Paragraph 0019) said fourth tube (Eaton 212), the elastomeric sleeve (McCullough 34) including perforations (McCullough 36) configured to allow release of said therapeutic molecules (the therapeutic agents described in McCullough Paragraph 0023) there through (McCullough Paragraphs 0021/0023).
As to Claim 12, McCullough, as modified, teaches all the limitations of Claims 1 & 9, and continues to teach the elastomeric sleeve (McCullough 34) is configured to closely surround at least a portion of (as shown in McCullough Figure 1) the inflatable balloon (McCullough 22) such that inflation of (McCullough Paragraph 0024) the inflatable balloon (McCullough 22) pushes therapeutic molecules (the therapeutic agents described in McCullough Paragraph 0023) contained within elastomeric sleeve (McCullough 34) through (as described in McCullough Paragraphs 0021/0023) the perforations (McCullough 36) of elastomeric sleeve (McCullough 34).
As to Claim 13, McCullough, as modified, teaches all the limitations of Claims 1 & 9, but does not teach at least one radiopaque marker provided near a distal portion of an element of said nasogastric device.
Eaton continues to teach at least one radiopaque marker (252) provided near (as shown in Figure 3A) a distal portion (4) of an element (222) of said nasogastric device (10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use at least one radiopaque marker, as taught by Eaton, on the first flexible tube, as taught by McCullough, as modified, “to fluoroscopically view and locate the distal portion of the balloon catheter assembly at a treatment site (Eaton Paragraph 0071)”.
As to Claim 14, McCullough, as modified, teaches all the limitations of Claim 1, and continues to teach ports (McCullough 146 is shown at the proximal end of McCullough 32/140; McCullough 46 is shown at the proximal end of the portion of McCullough tube 14 creating McCullough lumen 28; McCullough 58 is shown at the proximal end of the portion of McCullough tube 14 creating McCullough lumen 20; since Eaton 24, as described in Eaton Paragraph 0040) configured at the proximal ends (McCullough 146, McCullough 46, McCullough 58; Eaton 212a) of each of said four tubes (McCullough 32/140, the portion of McCullough tube 14 creating McCullough lumen 28, the portion of McCullough tube 14 creating McCullough lumen 20, and Eaton 212).
Claims 3 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough, in view of Eaton, further in view of Dykstra (U.S. Patent 4,410,320).
As to Claim 3, McCullough, as modified, teaches all the limitations of Claims 1-2, but is silent on the size of the perforations.
Dykstra describes a similar device, and teaches said perforations (16) have a length (Column 4, Lines 13-19) of between 1 and 8 millimeters (0.109 inches is approximately 2.667 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the length of the perforations, as taught by McCullough, as modified, between 1 and 8 millimeters, as taught by Dykstra, to be suitable for adults (Column 4, Lines 13-19).
As to Claim 6, McCullough, as modified, teaches all the limitations of Claims 1 & 5, and continues to teach at least a portion of said distal end (McCullough 150) includes (McCullough Paragraph 0036) perforations (McCullough 148)
McCullough, as modified, is silent on the perforations lengths, so does not explicitly teach the perforations have a length of between 1 and 3 millimeters.
Dykstra describes a similar device, and teaches said perforations (16) have a length (Column 4, Lines 13-19) of between 1 and 8 millimeters (0.109 inches is approximately 2.667 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the length of the perforations, as taught by McCullough, as modified, between 1 and 3 millimeters, as taught by Dykstra, to be suitable for adults (Column 4, Lines 13-19).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough, in view of Eaton, further in view of Heyns (U.S. PGPub 2014/0163528).
As to Claim 10, McCullough, as modified, teaches all the limitations of Claims 1-2, but does not teach said perforations are configured as semicircular patterns.
Heyns describes a similar device, and teaches said perforations (64) are configured as semicircular patterns (“C shape”; Paragraph 0062).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the perforations, as taught by McCullough, as modified, semicircular patterns, as taught by Heyns, to allow the first tube to “expand to bend in one direction and collapse to bend in the other direction (Paragraph 0062).”
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough, in view of Eaton, further in view of Heyns, further in view of Dykstra.
As to Claim 11, McCullough, as modified, teaches all the limitations of Claims 1-2 & 10, but is silent on the size of the perforations.
Dykstra describes a similar device, and teaches said perforations (16) are configured having lengths (Column 4, Lines 13-19) between 0.5 and 25 millimeters (0.109 inches is approximately 2.667 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the length of the perforations, as taught by McCullough, as modified, between 1 and 8 millimeters, as taught by Dykstra, to be suitable for adults (Column 4, Lines 13-19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Buras (4,693,243) and Steffen (10,035,003) teach similar devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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