DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. Claims 1-9, 11-13, 15-16, 18-28 and 30 were canceled. Claims 10, 14, 17, 29 and 31-33 are under consideration in this Office Action.
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.
3. Claims 10, 17 and 31-33 are rejected under 35 U.S.C. 103 as being obvious over Steinbach-Rankins et al., (US20160361382 published Dec. 2015; effectively filed June 2015) in view of Song et al., (US 20150209392 2015-01-222; priority to 2014-12-19), and Nagy et al., (eXPRESS Polymer Letters. Vol. 8., No.5., Pages 352-361, 2014).
The claims are drawn to a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising: implanting a composition into the reproductive tract of the female, wherein the composition comprises electrospun fibers comprising a probiotic and griffithsin-encapsulated nanoparticles embedded therein, wherein the composition provides sustained release of the griffithsin into the reproductive tract of the female, thereby inhibiting the growth and/or reducing the number of bacteria or virus in the reproductive tract of the female; wherein the probiotic is Lactobacillus acidophilus, L. crispatus, L. reuteri, L. jensenii and L. gasseri and wherein the prebiotic is selected from the group consisting of fructans, galactans, pectin, beta-glucans and xylooligosaccharides.
Steinbach-Rankins et al., teach methods of treating a viral infection are also provided and include administering to a subject an effective amount of a composition comprising an electrospun fiber having a surface and a biological adhesive moiety, griffithsin is conjugated to the surface of the electrospun fiber [abstract]. The biological adhesive moiety is a lectin. In some embodiments that make use of a lectin as a biological adhesive moiety, the lectin is griffithsin (GRFT) [para 9]. In addition to the electrospun fibers, the composition can also further comprise one or more polymer nanoparticles, with each of the one or more polymer nanoparticles encapsulating a biological adhesive moiety and/or anti-viral agent [para 11]. Example 12 teach GRFT encapsulated fibers and nanoparticles. Thus teaching claim 10. The method for treating a viral infection comprises administering to a subject an effective amount of a composition. The composition is administered intravaginally to thereby treat the viral infection. In some embodiments, the viral infection is selected from a herpes simplex virus 2 infection, a human immunodeficiency virus infection, a hepatitis C virus infection, and/or human papilloma virus infection, [para 12]. Thus teaching claim 31. FIG. 1 is a schematic diagram showing griffithsin (GRFT)-modified electrospun fibers (EFs) adhering to human immunodeficiency virus (HIV) in the vaginal lumen or mucosa, and preventing their entry through the underlying epithelium [para 14]. The composition can be implanted within the body of a subject and allow for sustained delivery of a therapeutic agent and sustained viral control over an extended time period. Through such sustained delivery of a therapeutic agent and without wishing to be bound by any particular theory or mechanism, it is believed that the administration of composition can be used to cure an individual of a chronic viral infection, such that a particular virus is no longer detected in the body of a subject [para 65]. Thus teaching claim 17. Steinbach-Rankins et al., teach a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising: implanting a composition into the reproductive tract of the female, wherein the composition comprises electrospun fibers comprising griffithsin-encapsulated nanoparticles embedded therein and additional agents, wherein the composition provides sustained release of the griffithsin into the reproductive tract of the female, thereby inhibiting the growth and/or reducing the number of bacteria or virus in the reproductive tract of the female; however Steinbach-Rankins et al., does not teach the inclusion of a probiotic or prebiotic.
Song et al., teach electrospun and/or nanofiber filaments comprising biological active agents, such as bacteria and viruses are known [para 2]. Song et al., provides a filament, such as a meltblown and/or dry spun and/or spunbond rather than electrospun, and/or micron diameter rather than nano diameter filament, comprising a microorganism that exhibits a viability and/or stability greater than known filaments comprising microorganisms [para 7]. Song et al., teach an additive comprises one or more release agents and/or lubricants [para 44]. The diameter of a filament of the present invention may be used to control the rate of release of one or more microorganisms [para 74]. Thus teaching sustained release. Song et al., teach one or more of the microorganisms may perform its function (i.e., treat) upon use by a human, by way of vagina in the animal. Non-limiting examples of products comprising filaments of the present invention that are intended for such use include feminine hygiene products, for example tampons, pads, panty liners [para 48]. Thus teaching claim 17.
The filaments of the present invention comprise one or more microorganisms wherein the bacteria is a probiotic such as [para 92, 94 and 97]. Non-limiting examples of Lactobacillus species for use in the filaments include L. acidophilus, L. crispatus, L. reuteri, L. jensenii and L. gasseri. In addition to one or more microorganisms, the filaments of the present invention may further comprise one or more prebiotics [para 110]. Non-limiting examples of suitable prebiotics include inulin, fructo-oligossacharides, gluco-oligosaccharides, glucan oligosaccharides, xylo-oligosaccharides, and mixtures thereof [para 111]. Thus teaching claims 32-33. The filaments are produced by spinning a filament-forming composition comprising one or more filament-forming materials and one or more microorganisms [para 125].
Nagy et al., teach the suitability of electrospinning for biodrug delivery and to develop an electrospinning-based method to produce vaginal drug delivery systems. Lactobacillus acidophilus bacteria were encapsulated into nanofibers [abstract]. Shelf life of the bacteria could be enhanced, which is an advantageous and patient-friendly way of administration. Viability testing showed that the nanofibers can provide long term stability for huge amounts of living bacteria. Thus the developed biohybrid nanowebs can provide new potential ways for curing bacterial vaginosis. Lactobacillus acidophilus is one of the most widely investigated and used species and it is an important part of normal human bacterial flora usually located in the urinary and genital tract of females [page 353, col. 1]. The most common vaginal disease, such as bacterial vaginosis is in connection with the lack of Lactobacillus bacteria and its substitution by exogenous bacteria [page 353, col. 1]. In normal vaginal microbiota, a huge number of Lactobacillus bacteria exist, which prevent the colonization and proliferation of pathogenic microorganisms through several ways [page 353, col. 2]. Several clinical studies showed that intravaginal administration of Lactobacillus acidophilus resulted in a significantly increased number of recoveries. Furthermore, a recent review drew attention to the increased importance of probiotic treatment for prevention of bacterial vaginosis so that more serious complications can be avoided [page 353, col. 2]. The formed nanofibrous product can be applied as an inexpensive and easy-to-use form that can be recommended for the treatment of bacterial vaginosis. An adequate dose of living bacteria could be stabilized using this effective and gentle technique, which is considered to be a feasible way to produce other biopharmaceuticals as well. Nagy et al., developed biohybrid nanowebs as a way for curing bacterial vaginosis [page 258, col.2]. Thus Song and Nagy et al., teach a method of inhibiting the growth and/or reducing the amount of a bacteria in a female, comprising a composition comprising probiotic electrospun fibers with implantation into the female reproductive tract.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Song and Nagy’s electrospun Lactobacillus acidolphilus nanofiber composition into the method of inhibiting the growth and/or reducing the amount of a bacteria in order to provide nanofiber with probiotic and prebiotics which provide for electrospun probiotic and prebiotic delivery to develop vaginal drug delivery systems when Steinbach-Rankins et al., already teach a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising the same intravaginal implantation steps as Song et al., to inhibit or reduce the amount of bacteria or virus. One of ordinary skill in the art would have a reasonable expectation of success by incorporating probiotic and GRFT
electrospun fibers because the fibers can be loaded with multiple agents have sustained release profiles to treat bacterial and viral infections. Furthermore, no more than routine skill would have been required to implant the electrospun Lactobacillus and prebiotic and GRFT electrospun polymer fibers, into the female reproductive tract as taught by Song et al., when Nagy et al., teach the nanofibrous product can be applied as an effective, inexpensive, in an easy to use and gentle format for the treatment of bacterial vaginosis.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of inhibiting infection, wherein there is no change in the respective function of the electrospun fibers, GRFT, probiotic or prebiotic, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
4. Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive. The rejection of claims 10, 17 and 31-33 under 35 U.S.C. 103 as being obvious over Steinbach-Rankins et al., in view of Song et al., and Nagy et al., as written above.
Applicants argue that the Examiner has not explained why a person of skill in the art would have been motivated to combine griffithsin with a probiotic and a prebiotic, particularly in a composition of electrospun fibers. Contrary to Applicants argument, the Office clearly explained why a person of skill in the art would have been motivated to combine griffithsin with a probiotic and a prebiotic, particularly in a composition of electrospun fibers in order to inhibit growth and/or reduce a number the amount of bacteria or virus in a reproductive tract of a female. Therefore, the Office clearly explained and supported with teachings from the prior art, the method of viral inhibition is the motivation of a person of skill in the art.
It would have been prima facie obvious at the time of applicants’ invention to apply Song and Nagy’s electrospun Lactobacillus acidolphilus nanofiber composition into the method of inhibiting the growth and/or reducing the amount of a bacteria in order to provide nanofiber with probiotic and prebiotics which provide for electrospun probiotic and prebiotic delivery for vaginal drug delivery systems because Steinbach-Rankins et al., already taught a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising the same intravaginal implantation steps just as Song et al., described inhibiting or reducing the amount of bacteria or virus. Therefore, a skilled person would understand electrospun probiotic and prebiotic delivery as vaginal drug delivery systems will adhere HIV in the vaginal lumen or mucosa, to prevent their entry through the underlying epithelium and thereby inhibit growth and quantity of the virus.
Applicants assert the Examiner has not explained why a person of ordinary skill in the art would have chosen to encapsulate griffithsin in nanoparticles. Applicants attention is directed to Steinbach-Rankins et al., who teach methods of treating a viral infection are also provided and include administering to a subject an effective amount of a composition comprising an electrospun fiber having a surface and a biological adhesive moiety, griffithsin is conjugated to the surface of the electrospun fiber. The composition can be implanted within the body of a subject and allow for sustained delivery of a therapeutic agent and sustained viral control over an extended time period. The sustained delivery can be used to cure an individual of a chronic viral infection, such that a particular virus is no longer detected in the body of a subject. Therefore, the Office Action clearly explained why a person of ordinary skill in the art would have chosen to encapsulate griffithsin in nanoparticles.
Applicants urge that the composition that is used in the claimed method is not taught or suggested by the cited references. Contrary to Applicants urgence, whether a skilled artisan would be motivated to make a combination includes whether he would select particular references in order to combine their elements. Objective indicia minimize hindsight's impact. And in this case, the objective indicia point to the obviousness of the claimed combination. Steinbach-Rankins et al., teach a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising: implanting a composition into the reproductive tract of the female, wherein the composition comprises griffithsin-encapsulated nanoparticles. Song et al., teach electrospun and/or nanofiber filaments comprising Lactobacillus acidophilus a probiotics and prebiotics, such as xylooligosaccharides for implantation into the reproductive tract of the female. Nagy et al., teach the suitability of an Lactobacillus acidophilus bacteria were encapsulated into nanofibers to produce vaginal drug delivery systems for curing bacterial vaginosis; thus inhibiting the growth and/or reducing the number of bacteria or virus in the reproductive tract of the female. Therefore, each and every limitation is described by the prior art references.
Applicants assert that "[s]urprisingly, the NP-EF delivery platform
demonstrated sustained-release for up to 90 days". However, Steinbach-Rankins et al.,
teach the composition can be implanted within the body of a subject and allow for sustained delivery of a therapeutic agent and sustained viral control over an extended time period. Thus, contrary to Applicants assertion, eletrospun griffithsin encapsulated nanoparticles having the ability to provide sustained release is not surprising. Moreover, Applicants have not presented any evidence to the contrary.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, there is no there is no knowledge gleaned only from the applicant's disclosure. Each and every limitation is taught by the prior art references.
Finally, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies i.e., Lactobacillus viability are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, none of Applicants arguments were found persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 103
5. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Steinbach-Rankins et al., Song et al., and Nagy et al., as applied to claims 10, 17 and 31-33 above, and further in view of Romero et al., (WO2015116375 published Aug 2015; priority to Jan 2014).
Claim 14 is drawn to the method wherein the bacteria is selected from the group consisting of Gardnerella vaginalis, Atopobium vaginae, and Neisseria gonorrhoeae.
Steinbach-Rankins et al., Song et al., and Nagy et al., have been discussed above as teaching a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising: implanting a composition into the reproductive tract of the female, wherein the composition comprises electrospun fibers comprising the Lactobacillus probiotic, the claimed prebiotic and griffithsin-encapsulated nanoparticles embedded therein, wherein the composition provides sustained release of the griffithsin into the reproductive tract of the female, thereby inhibiting the growth and/or reducing the number of bacteria or virus in the reproductive tract of the female. However, Steinbach-Rankins et al., Song et al., and Nagy et al., do not specifically teach the treatment of Gardnerella vaginalis, Atopobium vaginae, and Neisseria gonorrhoeae.
Romero et al., teach inhibiting transmission of a sexually transmitted infection [abstract]. The composition may prevent vaginal or rectal transmission of sexually transmitted infections (STIs), and is formulated accordingly [para 15]. The composition may include one or more additional antimicrobial agent, and/or a drug, including but not limited to a vaginally administrable drug, to provide a composition which may be administered to a subject to treat or prevent one or more conditions as a multipurpose prevention technology [para 16]. The method comprises administering an anti-microbial composition comprising an effective amount of Griffithsin (GRFT) to a subject in need thereof in order to inhibit infection by one or more of HIV, HSV-2, HPV, and other sexually transmitted infections (STIs) [para 22]. Thus teaching instant claim 10 and 31. Griffithsin are administered to a subject in need thereof in order to inhibit infection by HPV [para 19]. Griffithsin has shown excellent safety and efficacy against HIV in explant models, and modified forms of GRFT have been reported as having improved potency, stability, and solubility [para 10]. Griffithsin (GFRT or G) has been reported to have potent anti- HIV activity, and can block HIV replication in vitro at subnanomolar concentrations [para 8]. Other treatable STIs" are familiar to one of skill in the art and include, e.g., N. gonorrhoeae, C. trachomatis, bacterial vaginosis, T. vaginalis, Hepatitis B and others [para 71]. Thus teaching claim 14. The compositions may be suitably formulated e.g., into gels, creams, foams, films, tablets and suppositories, intravaginal rings, intrauterine devices or systems and nanofibers by one of skill in the art in accordance with standard techniques in the pharmaceutical industry [para 82]. Thus teaching introduction into the reproductive tract of the female just as instantly claimed. Factors for consideration in determining a dosage amount of an active antimicrobial agent are familiar to one of skill in the art and include the actual dosage form and manner of delivery of a pharmaceutical composition, e.g.., whether the dosage form is intended for extended release [para 62]. The methods comprise administering the compositions designed by one of skill in the art to achieve administration of a therapeutic dosage in an amount and over a period of time that is best suited to prevent or treat a microbial infection in a subject in need thereof. Such administration may be for extended release [para 83]. Thus teaching claim 17.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Romero et al., method of inhibiting the growth and/or reducing the amount of a bacteria and virus to the methods taught by Steinbach-Rankins et al., Song et al., and Nagy et al., because Steinbach-Rankins et al., Song et al., and Nagy et al., all teach implanting electrospun fiber comprising griffithsin in order to inhibit treatable infections where Romero et al., further teaches inhibiting STIs including N. gonorrhoeae and HIV, by interfering with their entry through the underlying vaginal epithelium. One of ordinary skill in the art would have a reasonable expectation of success by incorporating electrospun GRFT because electrospun fibers provide an effective way to deliver probiotics and prebiotics to the female reproductive tract by acting as a durable, surface-functionalized delivery platform. Furthermore, no more than routine skill would have been required to incorporate the electrospun fibers containing probiotic known treat additional well known bacterial and viral vaginal infections.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of inhibiting infection by bacterial and viral infections, wherein there is no change in the respective function of the GRFT-electrospun fibers, prebiotics or probiotic thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
6. Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive. The rejection of claim 14 under 35 U.S.C. 103 as being unpatentable over Steinbach-Rankins et al., Song et al., and Nagy et al., as applied to claims 10, 17 and 31-33 above, and further in view of Romero et al., as written above.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case,
it would have been prima facie obvious at the time of applicants’ invention to apply Romero et al’s method of inhibiting the growth and/or reducing STIs such as N. gonorrhoeae, C. trachomatis, bacterial vaginosis, T. vaginalis, Hepatitis B and other
virus to the methods taught by Steinbach-Rankins et al., Song et al., and Nagy et al., because Steinbach-Rankins et al., Song et al., and Nagy et al., all teach implanting electrospun fiber comprising griffithsin in order to inhibit treatable infections where Romero et al., teach inhibiting N. gonorrhoeae and HIV, by interfering with their entry through the underlying vaginal epithelium. Thus, one of ordinary skill in the art would have a reasonable expectation of success by incorporating electrospun GRFT because electrospun fibers provide an effective way to deliver probiotics and prebiotics to the female reproductive tract by acting as a durable, surface-functionalized delivery platform. Furthermore, no more than routine skill would have been required to incorporate the electrospun fibers containing probiotic known treat additional well known bacterial and viral vaginal infections.
Therefore, Applicants arguments are not found persuasive.
Claim Rejections - 35 USC § 103
7. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Steinbach-Rankins et al., Song et al., and Nagy et al., as applied to claims 10, 17 and 31-33 above, and further in view of Grooms et al., (Antimicrob Agents Chemother. 2016 Nov; 60(11): 6518–6531. Published online 2016 Oct 21. Prepublished online 2016 Aug 22).
Claim 29 is drawn to the sustained release being at least about 90 days.
Steinbach-Rankins et al., Song et al., and Nagy et al., have been discussed above as teaching a method of inhibiting growth and/or reducing a number the amount of bacteria or virus in a reproductive tract of a female, comprising: implanting a composition into the reproductive tract of the female, wherein the composition comprises electrospun fibers comprising a Lactobacillus probiotic, a prebiotic and griffithsin-encapsulated nanoparticles embedded therein, wherein the composition provides sustained release of the griffithsin into the reproductive tract of the female, thereby inhibiting the growth and/or reducing the number of bacteria or virus in the reproductive tract of the female. While, Steinbach-Rankins et al., Song et al., and Nagy et al., teach sustained release, none specifically teach the sustained release being at least about 90 days.
Grooms et al., teach Griffithsin (GRFT)-Modified Electrospun Fibers (EF) as a Delivery Scaffold To Prevent HIV Infection [abstract]. To offer physicochemical protection in a unique delivery vehicle, Grooms et al., designed a fabric scaffold, comprised of polymeric EFs, that integrates specific adhesive and antiviral properties to provide virus entry inhibition (Fig. 1 and 2)[ Introduction]. Figure 1 shows GRFT-modified EF’s adhering to HIV in the vaginal lumen or mucosa and preventing their entry through the underlying epithelium. The biological antiviral lectin GRFT was selected, as it has been demonstrated to bind to and to have antiviral efficacy against a variety of viruses, including HIV-1 and HSV-2. Furthermore, GRFT was shown to protect mice against intravaginal HSV-2 challenge, making it a leading protein-based antiviral candidate providing multipurpose protection against both HSV-2 and HIV-1 STIs [Introduction]. The EFs have the potential to offer an effective new way to present and/or deliver agents to the female reproductive tract by acting as a durable, surface-functionalized delivery platform [Introduction]. Grooms et al., teach intravaginal rings (IVRs) currently provide the “gold standard” for sustained release and have been demonstrated to deliver contraceptives and provide long-term protection against STIs for over 90 days [Discussion]. Thus teaching claim 29. The GRFT-EFs demonstrate efficacy against HIV-1 in vitro. Additionally, GRFT-EFs are not toxic to vaginal epithelial cells [Discussion].
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Grooms et al’s 90 day sustained release electrospun GFRT into the inhibition method of Steinbach-Rankins et al., Song et al., and Nagy et al., in order to inhibit HIV and HSV and provide long-term protection against STIs for over 90 days. One of ordinary skill in the art would have a reasonable expectation of success by incorporating electrospun GRFT because electrospun fibers provide an effective way to deliver agents to the female reproductive tract by acting as a durable, surface-functionalized delivery platform. Furthermore, no more than routine skill would have been required to incorporate the electrospun fibers, which are not toxic to vaginal cells.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of inhibiting infection by HIV, HSV and other viral infections, wherein there is no change in the respective function of the GRFT-electrospun fibers, Lactobacillus and prebiotics, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
8. Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive. The rejection of claim 29 under 35 U.S.C. 103 as being unpatentable over Steinbach-Rankins et al., Song et al., and Nagy et al., as applied to claims 10, 17 and 31-33 above, and further in view of Grooms et al., is maintained.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have a reasonable expectation of success by incorporating electrospun GRFT because electrospun fibers provide an effective way to deliver agents to the female reproductive tract by acting as a durable, surface-functionalized delivery platform. Moreover, no more than routine skill would have been required to incorporate the electrospun fibers, which are not toxic to vaginal cells. It would have been prima facie obvious at the time of applicants’ invention to apply Grooms et al’s 90 day sustained release electrospun GFRT into the inhibition method of Steinbach-Rankins et al., Song et al., and Nagy et al., in order to inhibit HIV and HSV and provide long-term protection against STIs for over 90 days.
Therefore, Applicants arguments are not found persuasive.
Pertinent Art
9. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Ebrahimnejad, P., Khavarpour, M., and Khalili, S. (Int. J. Eng. 30, 456–463.
2017) teach Survival of Lactobacillus acidophilus as probiotic bacteria using chitosan nanoparticles.
Wang, et al., (Journal of Pharmaceutical Sciences, vol. 99, No. 12. Dec. 2010) teach "A Novel Controlled Release Drug Delivery System for Multiple Drugs Based on Electrospun Nanofibers Containing Nanoparticles".
Fung et al., (J. Agric. Food Chem. 59, 8140–8147) teach L. acidophilus was incorporated into the spinning solution to produce nanofiber-encapsulated probiotic, measuring 229–703 nm, visible under fluorescence microscopy. Viability studies showed good bacterial survivability of 78.6–90% under electrospinning conditions and retained viability at refrigeration temperature during the 21 day storage study.
US2009/0061496A discloses electrospun and/or nanofiber filaments comprising biologically active agents, such as bacteria.
Sabater-Molina et al., (2009. J. Physiol. Biochem. 65, 315–328). Fructo-oligosaccharides occur naturally in plants and are composed of linear or branched chains of 2–60 fructose units. They are advantageous because they are non-sweet, calorie free, and non-cariogenic, and they are considered as soluble dietary fiber.
Jones et al., WO 2018183941 teach live biotherapeutics such as populations of live bacteria such as L. acidophilus, L. crispatus, L. reuteri, L. jensenii and L. gasseri, and suitable prebiotics include inulin, fructo-oligossacharides, gluco-oligosaccharides, glucan oligosaccharides, xylo-oligosaccharides, and mixtures thereof.
Ceylan et al., (Innovative Food Science & Emerging Technologies Volume 48, August 2018, Pages 212-218) teach Nanoencapsulation of probiotic bacteria (L. rhamnosus) into poly(vinyl alcohol) & sodium alginate-based nanofibers (VSPBe) and also the production of poly(vinyl alcohol) & sodium alginate-based nanofibers (VS) were successfully obtained.
Chen et al., (WO2018017929 published Jan 2018; effective filing date July 2016).
Chen et al., teach nanofiber structures such as rings and tubes are provided. The nanofiber structures comprise at least one rolled or spiral nanofiber membrane and at least one compound (e.g., drug or therapeutic agent). The nanofiber membranes may comprise electrospun nanofibers [Summary of Invention]. The methods of treating a disease or disorder in a subject in need thereof are provided. Chen et al., teach the nanofiber structures of the instant invention can be designed to allow for different types of drug release including but not limited to long-term sustained release, delayed release, tagged release, sequential release of multiple drugs, and parallel release of multiple drugs [Detailed Description].
Conclusion
10. No claims are allowed.
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/Primary Examiner, Art Unit 1645
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