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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/15/2025 has been entered.
Response to Amendment
The amendments filed on 06/19/2025 has been entered. Claims 26, 27, and 41 have been amended; claims 2-5, 7-10, 12, 14-18, 20-22, and 28-35 have been cancelled. Accordingly, claims 1, 6, 11, 13, 19, 23-27, and 36-44 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every 35. U.S.C. 112(b) rejection previously set forth in the Office action mailed on 07/15/2025. Therefore, all 35 U.S.C. 112(b) rejections are hereby withdrawn.
Response to Arguments
The affidavit under 37 CFR 1.132 filed is sufficient to overcome the rejection of claim 1 based upon the traversal made against the 35 U.S.C. 103 rejection, particularly the reference of Yeshurun US 2016/0243055 A1.
Applicant’s arguments, see Applicant’s Remarks and Affidavit, filed 10/15/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further search and consideration, a new ground(s) of rejection is made in view of Wilson et al. US 2005/0276836 A1 (previously cited) in view of Schoeling US 2002/0151859 A1 (previously cited) and Raz et al. WO 2019003163 A2 (newly cited).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 11, 36-39, 40, 41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. US 2005/0276836 A1 (previously cited, hereinafter Wilson) in view of Schoeling US 2002/0151859 A1 (previously cited, hereinafter Schoeling) and Raz et al. WO 2019003163 A2 (newly cited, hereinafter Raz).
Regarding claim 1, Wilson discloses a tampon 110 (Fig. 16D – tampon device 110) for delivering a therapeutic agent (Par. 2 – “The present invention concerns a vaginal device for delivering therapeutical and/or health-promoting agents”), comprising:
an absorbent tampon body 110 (Fig. 16D – “pledget” or tampon 110 body); and
said absorbent tampon body 110 (Fig. 16D) being provided with a pharmaceutical composition 112 (Par. 182 – “fiber coating or covering…”, and Par. 2 discusses “The coating of the device further comprises or is incorporated with a mucoadhesive composition comprising a therapeutical and/or health-promoting agent or a combination thereof”, such that the coating/covering “comprising… fiber, strip,…”; therefore, fiber 112 comprises or is incorporated with a mucoadhesive composition comprising a therapeutical agent), wherein the pharmaceutical composition 112 (Fig. 16D) further comprises a solidifying agent (Par. 59 – “the mucoadhesive composition comprising the therapeutical or health-enhancing agent is incorporated into a layer of a temperature-sensitive coating, such as, for example, wax…”) that softens at human body temperature (Par. 59 – “the coating melts upon insertion into the vagina…”), wherein the pharmaceutical composition 112 (Fig. 16D) is applied on a surface of the absorbent tampon body 110 (Par. 31 – “FIG. 16 shows a fiber coating or covering wherein in the fiber is… wound around the tampon (FIG. 16C and FIG. 16D)”), and wherein the pharmaceutical composition is for treating menstrual symptoms (Par. 279 – “Additionally, during the menstrual cycle when the pH of the vagina changes, the agent delivery systems additionally will contain buffers to stabilize pH of the vagina to enhance absorption”).
However, Wilson does not explicitly disclose an absorbent tampon body made of fibers; and a pharmaceutical composition comprising cannabidiol in a range from 2-200 mg.
Schoeling, in the same field of endeavor of tampon (Title), teaches an absorbent tampon body made of fibers (Par. 43 – “Preferably, the tampons are formed predominantly of fibers….”).
Raz, in the same field of endeavor of cannabinoid product for women health (Title) and in treating conditions/symptoms of menstrual cycle (Abstract), teaches a pharmaceutical composition (Par. 304 – “a therapeutically effective amount of a product…”) comprising cannabidiol (Par. 304 – “a therapeutically effective amount of a product comprising (i) at least one cannabinoid in a specific amount”, and Par. 305 – “According to an embodiment, the cannabinoids are selected from the group consisting… CBD…") in a range from 2-200 mg (Par. 304 – “the daily dose of the product comprises… about 2 milligram cannabinoid to about 200 milligram”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tampon body of Wilson to have the tampon body made of fibers as taught by Schoeling, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. The fiber as taught by Schoeling is also known to possess increased specific absorbency (Par. 43 of Schoeling).
Since Raz also teaches the use of cannabidiol in a tampon (Par. 304 – “the product is selected from the group consisting of… tampons”), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition of Wilson to further include cannabidiol as taught by Raz, in order to provide women with treatment for cramps and pelvic pain (Par. 477 of Raz), dysmenorrhea (Par. 481 of Raz), premenstrual syndrome (PMS) (Par. 486 of Raz).
Regarding claim 11, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not currently disclose wherein the absorbent tampon body has longitudinal channels disposed along the length of the absorbent tampon body.
Schoeling, in the same field of endeavor of tampon (Title), teaches wherein the absorbent tampon body 30 (Fig. 3 – tampon 30) has longitudinal channels 42 (Fig. 3-4 – longitudinal grooves 42) disposed along the length of the absorbent tampon body 30 (Fig. 3-4 – longitudinal grooves 42 extends across the length of tampon 30).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tampon body of the combination to further have the longitudinal channels as taught by Schoeling, in order to bring out an enlargement of the surface of the tampon and consequently an extension of the dwell time or absorption time for body fluid, which results in the absorption capacity and expansion capacity of the fiber core being improved considerably (Par. 39 of Schoeling). At the same time, a reduction in the weight of fibrous material used in the tampon 30 is thus possible, which allows more economical production of the tampon (Par. 39 of Schoeling).
Regarding claim 36, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. The combination further discloses a strip 112 (Fig. 16D of Wilson – fiber 112) comprising the effective amount (Par. 182 of Wilson – “fiber coating or covering…”, and Par. 2 discusses “The coating of the device further comprises or is incorporated with a mucoadhesive composition comprising a therapeutical and/or health-promoting agent or a combination thereof”, such that the coating/covering “comprising… fiber, strip,…”; therefore, fiber 112 comprises or is incorporated with a mucoadhesive composition comprising a therapeutical agent) of cannabidiol (Par. 304 of Raz), the amount of cannabidiol in the range from 2-200 mg (Par. 304 of Raz; Examiner notes that once the modification is made as discussed in claim 1, the pharmaceutical composition of Wilson will incorporate the CBD of Raz at the claimed amount; thus the limitation is met), the strip 112 (Fig. 16D of Wilson) positioned on the absorbent tampon body 110 (Fig. 16D of Wilson).
Regarding claim 37, Wilson in view of Schoeling in view of Raz suggests the invention of claim 36. The combination further discloses wherein the strip 112 (Fig. 16D of Wilson) radially extends around the surface of the absorbent tampon body 110 (Fig. 16D of Wilson – strip 112 circumferentially wraps around the surface of pledget 110).
Regarding claim 38, Wilson in view of Schoeling in view of Raz suggests the invention of claim 36. The combination further discloses wherein the strip 112 (Fig. 16D of Wilson) extends spirally on the surface of the absorbent tampon body 110 (Fig. 16D of Wilson; strip 112 circumferentially wraps around the surface of pledget 110) from a distal end of the absorbent tampon body 110 (Fig. 16D of Wilson – the spiral strip 112 starts at the distal end of pledget 110 that is nearby the string) to a proximal end of the absorbent tampon body 110 (Fig. 16D of Wilson – the black dot indicates an ending point of strip 112 from a proximal end of pledget 110).
Regarding claim 39, Wilson in view of Schoeling in view of Raz suggests the invention of claim 36. However, the combination does not currently disclose wherein the strip is longitudinally disposed in a straight line from a first distal end of the absorbent tampon body over a proximal end of the absorbent tampon body to a second distal end of the absorbent tampon body, the first distal end being opposite the second distal end.
Wilson, in another embodiment, teaches wherein the strip 102 (Fig. 15C-15D) is longitudinally disposed in a straight line (Fig. 15C-15D – vertical strip) from a first distal end of the absorbent tampon body 110 (Fig. 15C for a side view – from the end with the string) over a proximal end of the absorbent tampon body 110 (Fig. 15C-15D – to the rounded end without the string) to a second distal end of the absorbent tampon body 110 (Fig. 15C and Par. 181 – “strip 102 positioned over the tampon device”, hence the strip continues to the other side and reaches the other end with the string again as seen in Fig. 15C), the first distal end being opposite the second distal end (Fig. 15C – the two ends of strip 102 being opposite to each other; Par. 181 – strip 102 positioned over the tampon device, hence the strip continues to the other side and reaches the opposite end with the string again).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the strip of the combination that currently extends spirally around the tampon body that provides intravaginal treatment, for a strip vertically covers the tampon body, also as taught by Wilson, since these mechanisms perform the same function of providing therapeutic treatment into the vaginal tissue via absorption. Simply substituting a composition strip configuration for another would yield the predicable result of effective pharmaceutical composition being delivered into the body system via absorption through the mucus lining. See MPEP 2143. Also, since Wilson teaches both embodiments, the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Further, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manner by which the therapeutic agent is applied to define a vertical shape on the surface of the tampon body, since a modification would have involved a mere change in the form or shape of a component. A change in from or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaning from having the claimed shape. The modification would provide the same benefit of delivering an agent to the system to treat symptoms related to menstrual cycles.
Regarding claim 40, Wilson in view of Schoeling in view of Raz suggests the invention of claim 36. However, the combination does not currently disclose wherein the strip extends in a straight line from a proximal end to a distal end of the absorbent tampon body.
Wilson, in another embodiment, teaches wherein the strip 102 (Fig. 15C-15D) extends in a straight line (Fig. 15C-15D – vertical strip) from a proximal end 110 (Fig. 15C-15D – from the rounded end without the string) to a distal end of the absorbent tampon body 110 (Fig. 15C for a side view – to the end with the string).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the strip of the combination that currently extends spirally around the tampon body that provides intravaginal treatment, for a strip vertically covers the tampon body, also as taught by Wilson, since these mechanisms perform the same function of providing therapeutic treatment into the vaginal tissue via absorption. Simply substituting a composition strip configuration for another would yield the predicable result of effective pharmaceutical composition being delivered into the body system via absorption through the mucus lining. See MPEP 2143. Also, since Wilson teaches both embodiments, the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Further, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manner by which the therapeutic agent is applied to define a vertical shape on the surface of the tampon body, since a modification would have involved a mere change in the form or shape of a component. A change in from or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaning from having the claimed shape. The modification would provide the same benefit of delivering an agent to the system to treat symptoms related to menstrual cycles.
Regarding claim 41, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not currently disclose further comprising: a cylindrical cup that encapsulates the pharmaceutical composition, wherein the cylindrical cup surrounds a circumference of a proximal end of the absorbent tampon body.
Wilson, in another embodiment, teaches further comprising: a cylindrical cap 100 (Fig. 15A of Wilson – cap 100) that encapsulates the pharmaceutical composition (Par. 181 of Wilson – cap 100 covering where the [mucoadhesive composition] coating is), wherein the cylindrical cup 100 (Fig. 15A of Wilson) surrounds a circumference of a proximal end (Fig. 15A and Par. 181 of Wilson – cap 100 covering the proximal head of tampon device 110) of the absorbent tampon body 110 (Fig. 15A of Wilson).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the strip of the combination that currently extends spirally around the tampon body that provides intravaginal treatment, for a cylindrical cup covering the proximal end of the tampon body, also as taught by Wilson, since these mechanisms perform the same function of providing therapeutic treatment into the vaginal tissue via absorption. Simply substituting a composition configuration for another would yield the predicable result of effective pharmaceutical composition being delivered into the body system via absorption through the mucus lining. See MPEP 2143. Also, since Wilson teaches both embodiments, the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 43, Wilson in view of Schoeling in view of Raz suggests the invention of claim 41. The combination further discloses wherein the cylindrical cup 100 (Fig. 15A of Wilson) forms a container that encloses a space (Fig. 15A of Wilson – cap 100 has have a hollow space inside to cover over the proximal end of the tampon body 110) in which a pharmaceutical composition is contained (Par. 208 of Wilson – “Mucoadhesive compositions are… placed… in… a cap, cup… that act as their delivery vehicles…”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 1 above, and further in view of Lorenz et al. US 2018/0360739 A1 (previously cited, hereinafter Lorenz).
Regarding claim 6, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not disclose wherein the pharmaceutical composition further comprises cocoa oil.
Lorenz, in the same field of endeavor of composition application to the mucosal membrane (Abstract), teaches wherein the pharmaceutical composition further comprises cocoa oil (Par. 39 – “the inventive composition further comprises oil and/or butter. Optionally, the oil(s) and/or butter(s) is/are selected from the group consisting of oils and/or butters from… cocoa,…”).
Examiner notes that the composition of Lorenz also contains CBD for pain relief (Par. 58), and the composition can be impregnated into a tampon (Par. 63).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition of the combination to further have cocoa oil as taught by Lorenz, in order to produce the desired consistency of the composition (Par. 39 of Lorenz).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz in view of Lorenz as applied to claim 6 above, and further in view of US 2005/0203032 A1 (previously cited, hereinafter Yang et al).
Regarding claim 13, Wilson in view of Schoeling in view of Raz in view of Lorenz suggests the invention of claim 1. However, the combination does not disclose that the pharmaceutical composition further comprises beeswax.
Yang, in the same field of endeavor of compositions for vaginal treatment (Title), teaches that the pharmaceutical composition further comprises beeswax (Par. 49 – “Diverse additives are conveniently used as the emulsifier, and these include, but are not limited to… beeswax”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device to further include beeswax into the composition as taught by Lorenz, in order to provide an emulsifier, emollient to the composition (Par. 49 of Yang). The beeswax can further reduce volatilization of other bioactive ingredients, such as CBD, and prolong the life of the drug before usage. One of ordinary skill in the art would also recognize that beeswax can reduce friction and abrasion upon insertion, providing more comfortability for tampon users.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 1 above, and further in view of Olson et al. US 3,683,912 A (previously cited, hereinafter Olson) and Wennerblom et al. US 3,712,305 A (previously cited, hereinafter Wennerblom).
Regarding claim 19, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not disclose further comprising: a sock of a fiber-based material of thicker weave than the weave of fibers of the absorbent tampon body, the sock removably attached to the absorbent tampon body.
Olson, in the same field of endeavor of catamenial tampon (Col. 1, line 8-10), teaches further comprising:
a sock 12 (Fig. 1 – outer wrapper 12) of a fiber-based material (Col. 3, line 28-31 – “…outer wrapper of polypropylene fibers…”), the sock 12 (Fig. 1) removably attached to the absorbent tampon body 10 (Fig. 1 – the wrapper 12 is folded onto tampon body 10).
Wennerblom, in the same field of endeavor of tampon (Title), teaches further comprising:
a sock 17 (Fig. 9 – protective layer 17) of thicker weave (Col. 2, line 37-41 – “strong internal cohesion”) than the weave of fibers of the absorbent tampon body 15 (Fig. 9 – absorptive material layer 15, and Col. 2, line 37-41 – “a relatively thick inner layer of liquid absorptive material having a relatively weak internal cohesion and coated at the outer surface, at least, of the tampon, by a thin fibrous layer having a relatively strong internal cohesion ").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a fiber-based sock that covers the tampon body as taught by Olson, since Olson observed that having a sock as an outer wrap displayed a reduction in insertion force (Col. 4, line 44-46 of Olson).
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sock of the combination to further have the sock’s weave being thicker than the tampon body’s weave as taught by Wennerblom, in order to prevent any release of fibers from the inner layer (Col. 2, line 42 of Wennerblom) so that no loose filaments or fiber bundles can remain in vagina upon removing the tampon (Col. 7, line 27-28 of Wennerblom).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 1 above, and further in view of Olson and Osborn III et al. US 2006/0025740 A1 (previously cited, hereinafter Osborn).
Regarding claim 23, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not disclose a protective sock comprising hemp fiber wrapped around the absorbent tampon body.
Olson, in the same field of endeavor of catamenial tampon (Col. 1, line 8-10), teaches a protective sock 12 (Fig. 1 – outer wrapper 12) wrapped around the absorbent tampon body 10 (Fig. 1 and Fig. 4 – outer wrapper wraps the tampon body 10).
Osborn, in the same field of endeavor of tampon comprising an outer wrap (Title), teaches a protective sock 28 (Fig. 1 – outer wrap 28) comprising hemp fiber (Par. 26 – “the… outer wrap 28 material can be comprised of…natural fibers include… hemp…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a sock that covers the tampon body as taught by Olson, since Olson observed that having a sock as an outer wrap displayed a reduction in insertion force (Col. 4, line 44-46 of Olson). Furthermore, it is known that the sock can provide another layer of protection of short and loose fibers from the absorbent core (Col. 1, line 15-20 of Olson).
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the protective sock of the combination to further include hemp fiber as taught by Osborn, as all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of tampon, such as a tampon body and a protective sock made of hemp fiber. Modifying the combined device to have a protective sock comprising hemp fiber as taught by Osborn would not change the device’s function of being inserted into the vaginal canal and release the pharmaceutical composition. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the protective sock of the combination out of hemp fiber as taught by Osborn, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz in view of Olson in view of Osborn as applied to claim 23 above, and further in view of Wennerblom.
Regarding claim 24, Wilson in view of Schoeling in view of Raz in view of Olson in view of Osborn suggests the invention of claim 23. The combination further discloses wherein the protective sock 12 (Fig. 1 of Olson) is made of hemp fibers (Par. 26 of Osborn).
However, the combination does not explicitly disclose having a thicker weave than a weave of the hemp fibers of the absorbent tampon body.
Wennerblom, in the same field of endeavor of tampon (Title), teaches further comprising:
a sock 17 (Fig. 9 – protective layer 17) of thicker weave (Col. 2, line 37-41 – “strong internal cohesion”) than the weave of fibers of the absorbent tampon body 15 (Fig. 9 – absorptive material layer 15, and Col. 2, line 37-41 – “a relatively thick inner layer of liquid absorptive material having a relatively weak internal cohesion and coated at the outer surface, at least, of the tampon, by a thin fibrous layer having a relatively strong internal cohesion ").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sock of the combination to further have the sock’s weave being thicker than the tampon body’s weave as taught by Wennerblom, in order to prevent any release of fibers from the inner layer (Col. 2, line 42 of Wennerblom) so that no loose filaments or fiber bundles can remain in vagina upon removing the tampon (Col. 7, line 27-28 of Wennerblom).
Regarding claim 25, Wilson in view of Schoeling in view of Raz in view of Olson in view of Osborn in view of Wennerblom suggests the invention of claim 24. However, the combination does not currently disclose wherein the protective sock has ends that are sewn together.
Osborn, in the same field of endeavor of tampon comprising an outer wrap (Title), teaches wherein the protective sock 28 (Fig. 1) has ends that are sewn together (Par. 55 – “the closure mechanism 30 of the… outer wrap 28 can be any of the known variety including sewing. This could include gathering, such as bringing together of the outer wrap 28 at a longitudinal end to form a closure of the outer wrap 28 at that end…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ends of the protective sock of the combination to have them sewn together as taught by Osborn, in order to form a closure of the outer wrap/protective sock (Par. 55 of Osborn) and secure the protective sock onto the tampon body.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 1 above, and further in view of Tomsovic et al. US 2014/0115847 A1 (previously cited, hereinafter Tomsovic).
Regarding claim 26, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. The combination further discloses wherein the absorbent tampon body 110 (Fig. 16D of Wilson) comprises strips of hemp fibers (Par. 43 of Schoeling – “Preferably, the tampons are formed predominantly of fibers…. A useful, non-limiting list of cellulosics includes natural fibers such as… hemp,…”; Examiner that once the modification is made as discussed in claim 1, the fiber of Schoeling will be incorporated into the device of Wilson, including the hemp fiber; thus the limitation is met).
However, the combination does not explicitly disclose strips of the hemp fibers that are rolled.
Tomsovic, in the same field of endeavor of tampons used for feminine hygiene (Par. 1), teaches wherein the absorbent tampon body comprises strips of the hemp fibers that are rolled (Par. 1 – “Both types [of digitally insertable tampon and applicator style tampon] are usually made by… rolling rectangular strips of absorbent material into a blank…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hemp fiber strips of the tampon body of the combination to have them rolled as taught by Tomsovic, as Tomsovic states that it is one of the two known techniques of forming a tampon body (Par. 1 of Tomsovic). Therefore, it would have been within the skill of an artisan to select between the two known techniques of rolling versus folding as taught by Tomsovic, in this instant case, the chosen method is rolling, and produce no new and unexpected result that is an absorbent tampon body.
Regarding claim 27, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. The combination further discloses wherein the absorbent tampon body 110 (Fig. 16D of Wilson) comprises strips of hemp fibers (Par. 43 of Schoeling – “Preferably, the tampons are formed predominantly of fibers…. A useful, non-limiting list of cellulosics includes natural fibers such as… hemp,…”; Examiner that once the modification is made as discussed in claim 1, the fiber of Schoeling will be incorporated into the device of Wilson, including the hemp fiber; thus the limitation is met).
However, the combination does not disclose strips of the hemp fibers that are folded.
Tomsovic, in the same field of endeavor of tampons used for feminine hygiene (Par. 1), teaches wherein the absorbent tampon body comprises strips of the hemp fibers that are folded (Par. 1 – “Both types [of digitally insertable tampon and applicator style tampon] are usually made by folding… rectangular strips of absorbent material into a blank…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hemp fiber strips of the tampon body of the combination to have them folded as taught by Tomsovic, as Tomsovic states that it is one of the two known techniques of forming a tampon body (Par. 1 of Tomsovic). Therefore, it would have been within the skill of an artisan to select between the two known techniques of rolling versus folding as taught by Tomsovic, in this instant case, the chosen method is rolling, and produce no new and unexpected result that is an absorbent tampon body.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 41 above, and further in view of Gehling et al. US 2003/0045829 A1 (previously cited, hereinafter Gehling).
Regarding claim 42, Wilson in view of Schoeling in view of Raz suggests the invention of claim 41. However, the combination does not disclose wherein the cylindrical cup is fixed to the absorbent tampon body with a water-soluble adhesive.
Gehling, in the same field of endeavor of therapeutic agent delivery tampon (title), teaches the plies from the wall of a tampon is fixed with a water-soluble adhesive (Par. 35 – “The plies forming the wall 24 can be held together by an adhesive, such as glue, or by heat, pressure, ultrasonics, etc. The adhesive can be either water-soluble…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to incorporate a water-soluble adhesive to join the components of a tampon as taught by Gehling, since “a water-soluble adhesive is preferred for environmental reasons in that the wall will quickly break apart when it is immersed in water” (Par. 35 by Gehling). Similarly, one of ordinary skill in the art would have recognized that the cup attached to the tampon via a water-soluble adhesive will break down the adhesive to allow the composition in the cup to migrate within the cervical area, and upon disposal off the used tampon, any remaining parts of the attached cup will also “break apart and even dissolve in a relatively short period of time” (Par. 35 of Gehling).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Schoeling in view of Raz as applied to claim 1 above, and further in view of Manoryk et al. WO 2016133483 A1 (previously cited, hereinafter Manoryk).
Regarding claim 44, Wilson in view of Schoeling in view of Raz suggests the invention of claim 1. However, the combination does not currently disclose further comprising: a cellulose capsule on a proximal end of the absorbent tampon body, the cellulose capsule having rings and having a hollow chamber.
Wilson, in another embodiment, teaches a cellulose capsule 100 (Fig. 15A of Wilson, and (Par. 214-215 of Wilson – “The coating material is applied to the device as a… cap, cup… incorporated with the mucoadhesive composition…” and “Such coating may be… cellulose,…”) on a proximal end (Fig. 15A and Par. 181 of Wilson – cap 100 covering the proximal head of tampon device 110) of the absorbent tampon body 110 (Fig. 15A of Wilson), the cellulose capsule having a hollow chamber (Fig. 15A of Wilson shows that the cap 100 has to be a hollow chamber in order to cover the proximal end of the tampon device 110).
Manoryk, considered to be analogous art since the invention employs a tampon with a composition (Par. 149), teaches the capsule 93 (Fig. 25 – sac 93 alone) having ring 96 (Fig. 25 – waterproof rubber ring 96). Examiner notes that sac 93 can exist on its own as illustrated in Fig. 25, and sac 93 can be filled with a composition (Page 48, last paragraph named “Sac Corrugated”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the strip of the combination that currently extends spirally around the tampon body that provides intravaginal treatment, for a cylindrical cellulose cup covering the proximal end of the tampon body, also as taught by Wilson, since these mechanisms perform the same function of providing therapeutic treatment into the vaginal tissue via absorption. Simply substituting a composition configuration for another would yield the predicable result of effective pharmaceutical composition being delivered into the body system via absorption through the mucus lining. See MPEP 2143. Also, since Wilson teaches both embodiments, the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule of the tampon body of the combination to further have ring as taught by Manoryk, in order to provide a waterproof seal for the sac/capsule (Page 8, last paragraph of Manoryk named “Sac Corrugated” – waterproof rubber ring”). While the sac/capsule of Manoryk is attached to proximal head of a syringe (Fig. 25), Examiner contends that said sac can also be attached to a proximal head of a tampon body, given its considerably similar shape and operational mechanism, and since both composition-filled sac/capsule at the proximal head of any device ultimately performs the function of releasing the composition to treat an area on the body via absorption. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that as the capsule and rings are able to form a hermetically sealed environment to ensure sterility during shelf life (Page 32, third paragraph of Manoryk).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the ring of the combination to include a plurality of rings, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Therefore, one of ordinary skill in the art would have been motivated to incorporate more than one ring for the capsule, in order to provide extra sealing effect between the capsule and the tampon body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Epstein US 20200016116 A1
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781