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 .
This office action is in response to applicant’s communication of 1/15/2026. Currently claims 1-9, 11-15 are rejected below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-9, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sacco (US 4,309,995) in view of Shevgoor et al. (US 9,399,112) in view of Lee-Sepsick et al. (US 2009/0024108 A1).
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Sacco discloses a diffusing applicator (figure 3) comprising: a head unit (42) having a fluid receiving space and a plurality of dispensing passageways (48) in communication the fluid receiving space (47); an extension shaft (13/45) securely connected to the head unit; and a dispensing device (12) for holding a fluid and connected to the extension shaft, the dispensing device in communication with the plurality of dispensing passageways (48). Concerning the amended claim language of “the shaft frictionally engaging the fluid receiving space examiner is of the position that the shaft (13/45 is directly adjacent and “frictionally engaging the interior space of the “receiving space” (47). This is examiner’s current reading and position of the “frictionally engaging” claim language. Appropriate correction of the claim is recommended.
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Sacco discloses the claimed invention except for the “the plurality of secondary dispensing passageways having openings staggered along a liner length of the sidewalls”. Shevgoor teaches that it is known to use the plurality of secondary dispensing passageways having openings staggered along a liner length of the rigid sidewalls as set forth in figures 4a-4b and 20-21 and paragraph (column 3 lines 27-34 for one example) to provide increased flow efficiency through downstream diffusion holes. Shevgoor also discloses and teaches a rigid head unit with a conical front portion and a pair of tapering uniform walls extending from the front portion to a base portion as shown in figures 4a-4b and portions and around 426 area of the tapered wall portion to provide increased flow efficiency through downstream diffusion holes.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sacco with the plurality of secondary dispensing passageways having openings staggered along a liner length of the rigid sidewalls; and further a rigid head unit with a conical front portion and a pair of tapering uniform walls extending from the front portion to a base portion as taught by Shevgoor, since such a modification would provide the system with the plurality of secondary dispensing passageways having openings staggered along a liner length of the sidewalls and tapering uniform wall with a conical front portion for providing increased flow efficiency thorugh downstream diffusion holes (column 3 lines 27-34).
Concerning the amendment to the claim language that “the head unit is a rigid structure and does not include a porus or foam body”, examiner is of the position that a PHOSITA would know to form the device from a rigid (pore/foam free) material body. Shevgoor discloses that they it is known to construct tubing and catheter ends from polymer or metallic material.
Shevgoor para [0046] states:
(46) In some embodiments, the tubular body member 220 comprises an intravenous catheter. The intravenous catheter 220 generally comprises a flexible or semi-flexible biocompatible material, as commonly used in the art. In some embodiments, the intravenous catheter 220 comprises a polymer material, such as polypropylene, polystyrene, polyvinylchloride, polytetrafluoroethylene, and the like. In other embodiments, the intravenous catheter 220 comprises a metallic material, such as surgical steel, titanium, cobalt steel, and the like.
It is examiners position that as discussed above a PHOSITA would know to construct the device tip head from a rigid material in order to not collapse and deliver fluid to a patient and provide flow efficiency through the device.
Concerning the amendment to the claim language that “the dispensing passageways are the exclusive outlets for the fluid from the applicator” examiner is of the position that the passageways as shown in Shevgoor would show this as in figures 3a thorugh 4b for some examples (similar to applicant’s configurations as in applicant’s figures 1-9). Further concerning the claim language of the dispensing passageways re the exclusive outlets for the fluid see the assocated dispensing outlets of Sacco (48), and/or Sheevegor (outlets shown in figure 4A, and 4B for example),
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Sacco in view of Shevgoor discloses the claimed invention except for the ring shaped “slide“ member. Lee-Sepsick teaches that it is known to use a ring shaped slide member as set forth in element 4 as in figure 1A through 8 and the description of the “delivery device Stabilizer” to provide a means to control the distance between the shaft and stabilization ring of the device and the patients orifice that is being traversed. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sacco with a ring shaped slide member as taught by Lee-Sepsick, since such a modification would provide the system with a ring shaped slide member for providing a means to control the distance between the shaft and stabilization ring of the device and the patients orifice that is being traversed.
Examiner is of the position that the Slide 4 element of Lee-Sepsick teaches the claim language of “a slide positioned over and moveable along the extension shaft and positionable along the extension shaft to prevent the head unit from advancing forward in an orifice and positioning the head unit adjacent a cervix such that the primary and secondary dispensing passageways evenly distribute fluid about the cervix.” as element 4 has all the structural elements of the claimed limitation and performs the functional limitations of the claim.
Concerning claim 2 and the slide is positionable along the extension shaft to prevent the head unit from advancing forward in an orifice (see disclosure regarding element 4 in Lee-Sepsick).
Concerning claim 3 the slide is positionable along the extension shaft to prevent the head unit from advancing forward in an orifice (note disclosure in Lee-Sepsick regarding element 4).
Concerning claim 4 and the slide is a ring shaped member having an inner circumference sized to receive and bias outer walls of the extension shaft (see element 4).
Concerning claim 5 and a diffusing applicator comprising: a head unit having a fluid receiving space and a dispensing passageway in communication the fluid receiving space; an extension shaft securely connected to the head unit; a slide positioned over and moveable along the extension shaft; and a dispensing device for holding a fluid and connected to the extension shaft, the dispensing device in communication with the dispensing passageway (see previously identified structures above).
Concerning claim 6 and wherein the dispensing passageway is a single forward frontal discharge tip having angled outer sidewalls at an end thereof (see Sacco 38/50 passageways).
Concerning claim 7 and the head unit includes a rounded polished tip that sits flush with the extension shaft (note head unit 14 and extension shaft 40).
Concerning claim 8 and the dispensing passageway (50) is a side discharge passageway positioned on one side of the head unit (note angular side passageways of unit 14 as in figure 4).
Concerning claim 9 and comprising a second side discharge passageway positioned on another side of the head unit (see numerous 50 side passageways in figures 3-4).
Concerning claim 11 and the primary passageways and secondary passageways note Sacco figure 3, and Sheevegor figures 4A and 4B which shows multiple sets of passageways that could be considered primary and secondary passageways.
Concerning claim 12 and the primary passageways extend laterally, examiner is of the position that the multitude of passageways of Sacco 48 extend laterally, and further the Sheevegore passageways extend laterally as well as shown in figure 4A and 4B for examples and further figure 20 passageways 407 secondary and primary 706).
Concerning claim 13 and the secondary passageways extending at an angle see Sheevegore passageways extend laterally as well as shown in figure 4A and 4B for examples and further figure 20 passageways 407 secondary and primary 706).
Concerning claim 14 and the secondary passageways positioned rearward of the primary again note Sheevegore passageways extend laterally as well as shown in figure 4A and 4B for examples and further figure 20 passageways 407 secondary reward of primary 706).
Concerning claim 15 and the walls are made of a form of resilient polymer note the disclosure of Sheevegore discloses that the catheter may be formed of a flexible polymer material in the disclosure of the catheter may be formed of a flexible polymer“…such as polypropylene, polystyrene, polyvinylchloride, polytetrafluoroethylene, and the like…” as discussed in paragraphs [0046] and [0039].
Response to Arguments
Applicant's arguments filed 1/15/2026 have been fully considered but they persuasive in part and are not persuasive in part.
It is examiner position that as discussed above in the rejection the amendments to the claim language that “the head unit is a rigid structure and does not include a porus or foam body”, examiner is of the position that a PHOSITA would know to form the device from a rigid (pore/foam free) material body. Shevgoor discloses that they it is known to construct tubing and catheter ends from polymer or metallic material.
Shevgoor para [0046] states:
(46) In some embodiments, the tubular body member 220 comprises an intravenous catheter. The intravenous catheter 220 generally comprises a flexible or semi-flexible biocompatible material, as commonly used in the art. In some embodiments, the intravenous catheter 220 comprises a polymer material, such as polypropylene, polystyrene, polyvinylchloride, polytetrafluoroethylene, and the like. In other embodiments, the intravenous catheter 220 comprises a metallic material, such as surgical steel, titanium, cobalt steel, and the like.
It is examiners position that as discussed above a PHOSITA would know to construct the device tip head from a rigid material in order to not collapse and deliver fluid to a patient and provide flow efficiency through the device.
Concerning the amendment to the claim language that “the dispensing passageways are the exclusive outlets for the fluid from the applicator” examiner is of the position that the passageways as shown in Shevgoor would show this as in figures 3a thorugh 4b for some examples (similar to applicant’s configurations as in applicant’s figures 1-9). Further concerning the claim language of the dispensing passageways re the exclusive outlets for the fluid see the assocated dispensing outlets, and/or Sheevegor (outlets shown in figure 4A, and 4B for example),
The elements disclosed in the prior art of record are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
It is recommended that applicant amend the claims to greater define structure of the applicant’s inventions over the prior art of record and any obvious modifications thereof.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached on M-F 9-5 EST (FLEX).
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 on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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