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 .
Applicant repeatedly state that claim 17 has been withdrawn from consideration, and the claim status identifier for claim 17 also states “Withdrawn”. However, the Examiner does not understand applicant’s such statement because claim 17 has never been withdrawn (there was no restriction requirement made in present application), and claim 17 has been examined on the merit. Therefore, Applicant need to change the claim status identifier for claim 17 to --- (Previously Presented) ---.
THIS ACTION IS MADE FINAL. 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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tolcheyev et al (WO 2017/069721 A1) in view of Omar et al (“Universal Vaginal Applicator for the Uniform Distribution of Vaginal Gel and Cream Formulations: A Magnetic Resonance Imaging Study”, J. Obstet Gynaecol Can. Vol.36(1) (2014), pg.42-50), Schmolka (4,588,581), Keegan et al (4,001,151) and Stuart et al (US 2015/0136122 A1).
After stating that (pg.2, lines 21-29) that beta-glucan has been used to prevent viral infections, Tolcheyev teaches (pg.11, lines 4-12) a medicinal product comprising (i) beta-glucan (instant active agent of claim 16) and (ii) iota-carrageenan (instant thickening agent of claim 15) that is delivered in the form of a dry insufflation powder for treatment of conditions induced by viral intoxication. Tolcheyev teaches (claim 3 and pg.11, lines 21-24) that such dry insufflation powder can be used in the interior of vagina (in claim 3, Tolcheyev teaches that its antiviral pharmaceutical composition can be used in the form of insufflation powder in the interior of the human body), which means that the powder can be delivered intravaginally. Tolcheyev also states (pg.11, lines 25-27) that the dry insufflation powder composition can be administered by using an insufflator that can produce fine sprayed cloud of the dry powder. As to instant limitation of moisture content of the intravaginal formulation being below 5%, one skilled in the art reading Tolcheyev would surely understand (it would be commonsensical) that its dry insufflation powders are to be formulated as dry as possible to ensure proper aerosolization and delivery, as moisture can cause the powder to clump and clog the delivery device (such as an insufflator mentioned by Tolcheyev). Thus, one skilled in the art would find it obvious to keep the moisture content in Tolcheyev’s medicinal product (in the form of dry insufflation powder) as low as possible (i.e., close to 0%), and such moisture content would at least overlap with instant range (below 5%). Thus, Tolcheyev teaches or renders obvious instant intravaginal formulation comprising a dry powder composition with the moisture content below 5% (besides, instant claim language does not require the use or presence of an intravaginal formulation comprising a dry powder composition having the moisture content being below 5%. It simply requires instant apparatus to be “capable of” delivering an intravaginal formulation comprising a dry powder composition having the moisture content being below 5%).
Tolcheyev does not give detail as to how its medicinal product in the form of a dry insufflation powder is to be delivered to the interior of a vagina (i.e., intravaginally) other than generally stating that its dry insufflation powder composition can be used with an insufflator that can produce fine sprayed cloud of the dry powder. Omar first teaches (see Abstract (under Objective)) that conventional vaginal applicators with a single apical hole do not distribute vaginal formulations homogenously and do not cover the entire vaginal and cervical mucosa. To overcome this problem and offer women further protection against vaginal infections, Omar teaches an intravaginal applicator with multiple apical and lateral holes (see Fig.2). Omar’s intravaginal applicator (see the last applicator in Fig.1) has an open end connected to a plunger and a closed end with multiple apical holes. Omar demonstrates (see CONCLUSION) its intravaginal applicator provides uniform vaginal coverage with diverse vaginal products and that the coverage from this unique applicator was more uniform than commercial applicators with a single apical hole (see Fig.1). Thus, it would have been obvious to one skilled in the art to use Omar’s intravaginal applicator (with an open end and a closed end) having multiple apical and lateral holes) to deliver Tolcheyev’s dry insufflation powder intravaginally with a reasonable expectation that Omar’s applicator will provide uniform vaginal coverage for Tolcheyev’s dry insufflation powder. Thus, Tolcheyev in view of Omar teaches instant elongated tube which is at least partially covered with openings and having an open and a closed end for dispensing the intravaginal formulation.
Tolcheyev in view of Omar does not teach instant pressurized container. However, it is known in the art, as evidenced by Schmolka (col.2, lines 20-25), that a composition delivered from an aerosol container provides improved coverage for intravaginal application. Furthermore, it is also known in the art, as evidenced by Keegan (see Example 6), that an aerosol container (with a propellant added to the container) can be used for powder delivery. Since both Omar’s intravaginal applicator and intravaginal application using aerosol container (with propellant) are individually taught to be useful for the same purpose (i.e., achieving improved coverage or uniform coverage), it would have been obvious to one skilled in the art to use Omar’s intravaginal applicator combined with Keegan’s aerosol container (with a propellant) by connecting the open end of Omar’s applicator (distributor) to Keegan’s aerosol container (instead of to a plunger) (it would be within the realm of one skilled in the art to work out the details as to how to make such connection) to deliver Tolcheyev’s dry insufflation powder into a vagina with a reasonable expectation of success in providing improved (or uniform) coverage. MPEP 2144.06 states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be use for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Keegan’s aerosol container (with a propellant) teaches instant pressurized container.
Although Keegan does not explicitly teach that its aerosol container includes a valve that operates a spray nozzle, as evidenced by Stuart (see abstract and [0043]), an aerosol container is known to include a valve that controls the flow of material through a nozzle (in [0096], Stuart also teaches that the material can be delivered to the vagina). Thus, it would be obvious to one skilled in the art to have a valve that operates a spray nozzle of Keegan’s aerosol container (instant pressurized container) with a reasonable expectation of being able to control the flow of the material (to be delivered) through the spray nozzle . Thus, Keegan in view of Stuart teaches instant valve that operates a spray nozzle of the pressurized container.
With respect to instant “the open end being suitable to connect to the valve operating spray nozzle of the pressurized container”, it is the Examiner’s position that one skilled in the art would easily be able to connect the open end of Omar’s vaginal applicators to the valve (which is taught by Keegan in view of Stuart) operating spray nozzle of Keegan’s aerosol container provided with the propellant (instant pressurized container).
With respect to the limitation “wherein the theoretical internal diameter of each opening is more than the particle size of the dry powder composition”, the Examiner already established above that it would be obvious to one skilled in the art to use Omar’s intravaginal applicator having multiple apical and lateral holes combined with Keegan’s aerosol container (with propellant) to deliver Tolcheyev’s dry insufflation powder, and it would be commonsensical to have the theoretical internal diameter of each of those apical and lateral holes in Omar’s intravaginal applicator to be larger than the particle size of Tolcheyev’s dry insufflation powder so that the particles would not clog the apical and lateral holes of Omar’s intravaginal applicator.
Thus, Tolcheyev in view of Omar, Schmolka, Keegan and Stuart renders obvious instant apparatus of claims 12, 15 and 16, which is “capable of” delivering intravaginal formulation comprising a dry powder composition having the moisture content below 5%.
With respect to instant claim 13, Omar’s Fig.1 indicates that its vaginal applicator is about 9-10 cm in length (as estimated by the Examiner). Thus, Tolcheyev in view of Omar, Schmolka, Keegan and Stuart renders obvious instant claim 13.
With respect to instant claim 14, Omar teaches (pg.47, 2nd paragraph under DISCUSSION) that the tube is disposable (a single use only). Thus, Tolcheyev in view of Omar, Schmolka, Keegan and Stuart renders obvious instant claim 14.
With respect to instant claim 19, even though Keegan does not expressly state whether its aerosol container is a multi-dose container or a single dose container, since it can only be either a multi-dose container or a single-dose container, Tolcheyev in view of Omar, Schmolka, Keegan and Stuart renders obvious instant claim 19.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tolcheyev et al (WO 2017/069721 A1) in view of Omar et al (“Universal Vaginal Applicator for the Uniform Distribution of Vaginal Gel and Cream Formulations: A Magnetic Resonance Imaging Study”, J. Obstet Gynaecol Can. Vol.36(1) (2014), pg.42-50), Schmolka (4,588,581), Keegan et al (4,001,151) and Stuart et al (US 2015/0136122 A1), as applied to claim 12 above, and further in view of Kurokawa et al (“Efficacy of traditional herbal medicines in combination with acyclovir against herpes simplex virus type 1 infection in vitro and in vivo”, Antiviral Research, vol.27 (1995), pg.19-37).
Tolcheyev in view of Omar, Schmolka, Keegan and Stuart does not teach instant herbal extract. Tolcheyev’s inventive composition is used for treating viruses such as herpes simplex virus (HSV) (see pg.15, lines 1-17). Kurokawa indicates (see abstract) that it is well known in the art that herbal extracts from Geum japonicum Thunb., Rhus javanica L., Syzygium aromaticum (L.) Merr. et Perry, or Terminalia chebula Retzus show strong anti-HSV-1 activity when combined with other antiviral medications. It would be obvious to one skilled in the art to use herbal extracts from those plants listed above in Tolcheyev’s antiviral pharmaceutical composition with a reasonable expectation of obtaining strong anti-HSV-1 activity. Thus, Tolcheyev in view of Omar, Schmolka, Keegan and Stuart, and further in view of Kurokawa renders obvious instant claim 17.
Response to Arguments
Applicant first argue that the Office Action asserts, without evidence, that Tolcheyev’s insufflation powders have below 5% moisture and that nothing in Tolcheyev teaches or suggests this moisture limitation set forth in the claims. However, first of all, Tolcheyev teaches that its antiviral pharmaceutical composition can be used in the form of dry insufflation powder and state that such dry insufflation powder composition can be administered by using an insufflator that can produce fine sprayed cloud of the dry powder. One skilled in the art reading Tolcheyev would surely understand (it would be commonsensical) that its dry insufflation powders would need to be formulated as dry as possible to ensure proper aerosolization and delivery, as moisture can cause the powder to clump and clog the delivery device (such as an insufflator mentioned by Tolcheyev). Thus, one skilled in the art would find it obvious to keep the moisture content in Tolcheyev’s medicinal product (in the form of dry insufflation powder) as low as possible (i.e., close to 0%), and such moisture content would at least overlap with instant range (below 5%). Secondly (and more importantly), it is to be noted that instant claim language does not actually require the use or presence of an intravaginal formulation comprising a dry powder composition having the moisture content being below 5%. It simply requires instant apparatus to be “capable of” delivering an intravaginal formulation comprising a dry powder composition having the moisture content being below 5%.
Applicant point to pg.11-12 of Tolcheyev, which states the following
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and argue that Tolcheyev seeks a fine sprayed cloud of material for functionality of its insufflation powder. Applicant argue that such fine sprayed clouds are antithetical to Omar’s delivery apparatus since Omar relates to a specific device for applying cream or gel compositions, not insufflation powders: applicant point to pg.44 of Omar where it describes its applicator (Universal Vaginal Applicator or UVA) shown in Figure 1 and also to pg.44, col.1 where Omar states “[w]e wished to determine whether the UVA can be generally used with any vaginal gel or cream” and argue that Omar’s device is for use with creams and gels (where the device has a prefilled reservoir prefilled with gel or cream, and once the membrane (covering the opening of the reservoir) is removed prior to use, the gel or cream product can be communicated through the opening to the distributor having holes) and nowhere does Omar indicate that its device would be useful for insufflation powders. Applicant further argue that in Omar’s device, there is no need for propellant or reservoir pressurization, and that the presence of propellant or reservoir pressurization would not make sense because removing the membrane from the prefilled reservoir would allow propellant to escape and depressurization to occur. Applicant argue that propellant and/or reservoir pressurization would not help with distribution of Omar’s gel/cream product with Omar’s device. The Examiner disagrees. First of all, as already discussed above, Omar first states that conventional vaginal applicators with a single apical hole (as is the case with the insufflator mentioned in Tolcheyev) do not distribute vaginal formulations homogenously and do not cover the entire vaginal and cervical mucosa. In order to overcome this problem, Omar teaches a vaginal applicator with multiple apical and lateral holes (as seen in Fig.2) and demonstrates (see CONCLUSION) that its vaginal applicator provides uniform vaginal coverage with diverse vaginal products and that the coverage from this unique applicator was more uniform than commercial applicator with a single apical hole. Thus, it would have been obvious to one skilled in the art to use Omar’s vaginal applicator (with an open end and a closed end) having multiple apical and lateral holes for delivering Tolcheyev’s medicinal product in the form of a dry insufflation powder intravaginally so as to distribute the medicinal product in the form of a dry insufflation powder homogenously and to provide uniform vaginal coverage for the entire vaginal and cervical mucosa. The desire to distribute vaginal formulations homogeneously and provide uniform vaginal coverage would be the same whether the vaginal product is a dry powder composition, gels or creams (besides, Omar never teaches that its applicator having multiple apical and lateral holes cannot be practiced with a dry powder composition). Secondly, although Tolcheyev’s dry insufflation powder is neither cream nor gel, it is well known in the art (see the 1st and 3rd paragraphs of Wikipedia article on “Fluidization” which is obtained from the website: https://en.wikipedia.org/wiki/Fluidization) that when gas (propellant) is passed up through granular material (such as dry powder), the granular material is converted from a static solid-like state to a dynamic fluid-like state. This process is called fluidization. When fluidized, a bed of solid particles (such as dry powder) will behave like a fluid, liquid or gas. As further evidenced by Zhao (“Rheology of gas-solid fluidized bed”, Fuel Processing Technology, vol.68(2), November 2000, pg.153-160, as obtained from the website: https://www.sciencedirect.com/science/article/pii/S0378382000001223 ) (see under “Introduction”), fluidized beds (i.e., fluidized bed of solid particles) can be characterized as non-Newtonian fluids, and creams and gels are also non-Newtonian fluids (see Wikipedia article on “Non-Newtonian fluid” obtained from the website: https://en.wikipedia.org/wiki/Non-Newtonian_fluid - see the table titled “Comparison of non-Newtonian, Newtonian and viscoelastic properties”). Since aerosolized dry powder (such as Tolcheyev’s dry insufflation powder) behaves like a non-Newtonian fluid when fluidized, just as a cream or gel does, it would be obvious to one skilled in the art to use Omar’s vaginal applicator (with an open end and a closed end) having multiple apical and lateral holes for delivering Tolcheyev’s dry insufflation powder intravaginally with a reasonable expectation of success in distributing the dry insufflation powder into the vagina homogenously and uniformly. Thirdly, the Examiner would agree with applicant argument that in Omar’s device, there is no need for propellant or reservoir pressurization and that propellant and/or reservoir pressurization would not help with Omar’s device if the product to be distributed using Omar’s device were gel/cream product. However, in instant 103 rejection, it would be Tolcheyev’s dry insufflation powder that is to be distributed with Omar’s device, not Omar’s gel/cream product. As already discussed above, it is known in the art, as evidenced by Schmolka (col.2, lines 20-25), that a composition delivered from an aerosol container provides improved coverage for intravaginal application, and it is also known in the art, as evidenced by Keegan (see Example 6), that an aerosol container with a propellant added to the container can be used for powder delivery. Since both Omar’s intravaginal applicator and intravaginal application using aerosol container are individually taught to be useful for the same purpose (i.e., improved coverage or uniform coverage), it would have been obvious to one skilled in the art to combine Omar’s intravaginal applicator with Keegan’s aerosol container having propellant (instant pressurized container) by connecting the open end of Omar’s applicator to Keegan’s aerosol container (instead of to a plunger) and to use such modified applicator to deliver Tolcheyev’s dry insufflation powder into the vagina with a reasonable expectation of providing improved (or uniform) coverage for intravaginal application. MPEP 2144.06 states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be use for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Applicant next argue that Omar’s device with its distributor tube would not allow for Tolcheyev’s desired fine sprayed clouds of product for uniform distribution — the majority of the cloud would likely be impeded by the Omar’s distributor tubing, with only minor amounts escaping through the holes of the tubing. The Examiner disagrees, When one uses Omar’s intravaginal applicator having multiple apical and lateral holes (combined with Keegan’s aerosol container having propellant) to deliver Tolcheyev’s dry insufflation powder, it surely would be sensible and practical to have the theoretical internal diameter of each of those apical and lateral holes in Omar’s intravaginal applicator to be larger than the particle size of Tolcheyev’s dry insufflation powder so that the particles would not clog the apical and lateral holes of Omar’s intravaginal applicator. This would result in fine sprayed clouds of Tolcheyev’s dry insufflation powder as desired by Tolcheyev. The only difference would be that the fine sprayed clouds of the powder would be distributed more uniformly (due to Omar’s device having multiple apical and lateral holes). Since the internal diameter of each of the apical and lateral holes in Omar’s intravaginal applicator is to be larger than the particle size of Tolcheyev’s powder, the Examiner disagrees with applicant’s argument that the majority of the cloud would likely be impeded by Omar’s distributor tubing and that only minor amounts would escape through the holes of the tubing.
As to the Examiner’s assertion that it would have been obvious to use a pressurized container in combination with Omar’s apparatus and Tolcheyev’s insufflation powder, applicant argue that the Examiner’s such assertion ignores the fact that (1) Omar is limited to gels and creams, (2) Omar’s reservoir, when combined with Omar’s distributor, could not have been modified to be pressurized or contain propellant; and/or (3) the majority of any cloud from Tolcheyev’s insufflation would likely be impeded by the Omar’s distributor tubing, with only minor amounts escaping through the holes of the tubing. Applicant argue that one skilled in the art, seeking to modify Tolcheyev, would not be motivated to combine a pressurized container (with propellant) with Omar’s distributor tubing to attempt to create Tolcheyev’s desired cloud of insufflation powder for vaginal administration given the limitations of the distributor tubing and argue that this is particularly true given that Omar only relates to gels and creams and never even hints that insufflation powder can be used instead. Applicant further argue that one of ordinary skill in the art would not have any reasonable expectation of success by modifying Omar’s device to allow for a pressurized container to produce a cloud of product for vaginal application. Applicant argue that one skilled in the art would not have any reason to expect that enough product could escape through the holes in the tubing to allow for successful application of product. The Examiner disagrees. First of all, the Examiner believes that applicant’s points (1) and (3) (as stated above) were already addressed above in this paragraph. Secondly, as to the point (2) concerning the pressurized container with the propellent, as already discussed above, although Tolcheyev in view of Omar does not teach instant pressurized container, since it is already known in the art (as evidenced by Schmolka and Keegan) that a powdery composition delivered from an aerosol container (with a propellant added to the container) provides improved coverage for intravaginal application, one skilled in the art would have been motivated to combine Omar’s intravaginal applicator with Keegan’s aerosol container (with a propellant added to it) by connecting the open end of Omar’s distributor to Keegan’s aerosol container (instead of to a plunger) (it would be within the realm of one skilled in the art to work out the details as to how to make such connection) and use such combined equipment to deliver Tolcheyev’s dry insufflation powder into a vagina so as to provide improved (or uniform) coverage. As to a reasonable expectation of success, as addressed above, when one uses Omar’s intravaginal applicator having multiple apical and lateral holes (combined with Keegan’s aerosol container having propellant) to deliver Tolcheyev’s dry insufflation powder, it surely would be sensible and practical to have the theoretical internal diameter of each of those apical and lateral holes in Omar’s intravaginal applicator (distributor) to be larger than the particle size of Tolcheyev’s dry insufflation powder so that the particles would not clog the apical and lateral holes of Omar’s intravaginal applicator. This would result in fine sprayed clouds of Tolcheyev’s dry insufflation powder as desired by Tolcheyev, and the only difference would be that the fine sprayed clouds of the powder would be distributed more uniformly in the vagina due to Omar’s device having multiple apical and lateral holes. Since the internal diameter of each of the apical and lateral holes in Omar’s intravaginal applicator would be larger than the particle size of Tolcheyev’s powder, one skilled in the art would reasonably expect that sufficient amounts of the powdery product would escape through the holes of the tubing to allow for successful application of the product.
For the reasons stated above, instant 103 rejections over Tolcheyev in view of Omar, Schmolka, Keegan and Stuart still stand.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
November 13, 2025