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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 23, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 and 37 which are the two independent claims recite “the intravaginal composition reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6”. There is no mention of measuring sperm motility, a numerical degree of sperm motility reduction, or any particular ratio of intravaginal composition and semen that is linked to any particular functional outcome of the composition. The applicant’s remarks highlight paragraphs 45 and 57 as providing basis for the amendment. Neither the specification of record nor the PGPub version of the application provides any discussion of the limitations that are now recited. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as claimed at the time of filing.
This is a new matter rejection.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21 and 37 which are the two independent claims recite “the intravaginal composition reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6”. It is unclear which, if any, structural limitations are required of the composition, beyond those already recited, in order to fulfill this limitation. Since there is no written basis for this limitation in the disclosure, there is no supporting detail to elaborate on a structure-function correlation that corresponds to the recitation. In addition, the recitation does not state if the ratio is on a mass or volume basis; thus the functionality required is also unclear due to this omission. Therefore the metes and bounds of the claims are unclear.
Claims that are rejected but are not elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
For the sake of application of prior art, the limitations at issue will be considered met when the recited structure of the claims have been met.
Claim Interpretation
The claims recite “purified L-lactic acid or produced by a recombinant yeast or bacterium”. These are product by process recitations. ““’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. The term “purified” implies the removal of some component or components, but it is not specific as to their identity; thus no specific structure is implied by the term. In addition, the constraints on the recited composition comprising “purified L-lactic acid” are no different than a composition comprising L-lactic acid because other unrecited components are permitted. There is no evidence that the structure of L-lactic acid made via recombinant yeast or bacterium is any different than that made via other routes. While a racemic mixture of lactic acid enantiomers may occur, depending on the synthetic route, the claimed composition is recited with open language. Therefore other components that are present along with the L-lactic acid are permitted in the composition as unrecited components. Thus L-lactic acid from any source, regardless of whether it has undergone purification, meets the limitation of the L-lactic acid in the instantly claimed composition “comprising…purified L-lactic acid or produced by a recombinant yeast or bacterium”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-31 and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Garg et al. (previously cited) in view of Moench et al. (previously cited), Lee et al. (previously cited), Seto et al. (previously cited), and Segeren et al. (previously cited).
Garg et al. teach a method of preventing pregnancy via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25; instant claim 21). The composition is applied within the vagina (intravaginal application) prior to or as soon as possible after sexual activity, where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36; instant claims 21, 29, and 30). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours(see column 5 line 65-column 6 line 5). As a consequence, Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some sexually transmitted disease (STD) microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent and has a preferred molecular weight of 20,000 to 250,000 g/mol (see column 11 lines 12-18; instant claims 21, 31, and 40). The alginic acid forms a matrix due to interactions with divalent cations in seminal fluid that are not present in the vaginal fluid (see column 11 lines 21-23). The bioadhesive agent is envisioned as xanthan gum as well as hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose (see column 11 lines 42-46; instant claim 25). An example is provided with 4.25% alginic acid, 3% xanthan gum (bioadhesive agent), 8% glycerol (thickener/humectant), 2% lactic acid (buffering agent), 1% citric acid (buffering agent), 0.4% potassium bitartrate (buffering agent), 0.2% benzoic acid (buffering agent), 0 to 10% nonoxynol-9, and water (see example 1 and example 5 table VI; instant claims 21, 23-28, and 36-37). D-lactic acid is not a recited or required component, therefore a racemic mixture also is not recited as required (see instant claims 21 and 37). The composition has a pH of 3.5 to 3.6 (see instant claim 22 and 38). Both lactic acid and citric acid are taught as buffering agents in the compositions (see column 11 lines 55-60). Further, Garg et al. detail application whose occurrence is preferably prior to sexual activity; however post-sexual activity application is also contemplated and encouraged to occur as soon as possible after sexual activity, which explicitly include immediately, within fifteen minutes, and within an hour (see column 13 line 59-column 14 line 2; instant claims 29-30). The composition of example 1 also demonstrates the ability to stop sperm motility when undiluted and when diluted (see example 4 and example 10). Garg et al. is silent in regard to the ratio of mannuronate to guluronate in their alginic acid as well as the enantiomer of lactic acid.
Moench et al. teach compositions that comprise L-lactic acid for inactivating pathogens in the female genital tract (see abstract). They further teach that both D-lactic acid and L-lactic acid are products of the native flora of the vagina (see paragraph 3). The average L-lactic acid concentration has been measured at 1.2% and pharmaceuticals seek to mimic the acidic environment to provide a protective environment against sexually transmitted pathogens (see paragraph 4). This and other low molecular weight acid buffers have been employed at concentrations higher than that which occur naturally in order to overcome the ability of the alkalinity of semen to compromise the protective vaginal acidity (see paragraph 4). Moench et al. further teach that compositions with L-lactic acid that are substantially free of D-lactic acid reduce potential epithelial toxicity as compared to D-lactic acid or a racemic mixture of L- and D- lactic acid (see paragraphs 4 and 6). The L-lactic acid was also found to be a highly effective microbicide against sexually transmitted pathogens (see paragraph 7).
Lee et al. teach that the guluronate blocks in alginic acid are responsible for the intermolecular crosslinking due to divalent cations (see page 108 first column first full paragraph). They go on to note that the ratio of mannuronate to guluronate (M/G) is one of several critical factors that affect the physical properties of alginic acid and its hydrogel (see page 108 first column first full paragraph).
Segeren et al. teach alginic acids with various ratios of mannuronate to guluronate. Specifically they teach ratios of 0.4, 1.1, and 1.14 (see table 1; instant claims 21, 33-35 and 38-39).
Seto et al. teach an alginic acid based composition that is envisioned for application to skin or mucosa (see abstract). They go on to teach the composition for vaginal application (see paragraph 16). Seto et al. further teach that the M/G ratio is not particularly limited; however the smaller the value the faster the onset of gelation which is a desired outcome for Seto et al. (see paragraph 63). They point to a most preferred range of 1 or less where lower values are preferred so as to improve retention at the application site (see paragraph 63; instant claims 33-34 and 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the direction of Garg et al. and practice their method of contraception with an exemplified composition in the absence of nonoxynol-9. It also would have been obvious to include xanthan gum alone or in combination with another bioadhesive agent because “[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 used 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) (see MPEP 2144.06). Given the teachings of Moench et al. of the epithelial toxicity that occurs due to the presence of D-lactic acid and the benefits of L-lactic acid, it would have been obvious to one of ordinary skill in the art at the time of the invention to select the L enantiomer for the lactic acid and exclude the D-enantiomer of lactic acid (e.g., a ‘purified’ L-lactic acid). Since the premise of the functionality of the composition of Garg et al. is based upon the divalent cations from seminal fluid crosslinking the alginic acid and the responsibility for this functionality lies with the guluronate, it also would have been obvious to select an alginic acid with more guluronate than mannuronate units. This choice would have also been obvious because it is highlighted by Seto et al. as being preferred so as to gel quickly and be retained at a mucosal application site, such as the vagina. This range of M/G ratio being less than 1 overlaps or embraces those that are claimed, including “about 0.7”. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05; instant claim 34). There is no evidence of the criticality of any of the claimed ranges, therefore the overlapping/embracing range of Seto et al. renders them obvious. Given known M/G ratios that range from 0.4 to 1.14, as taught by Segeren et al., a selection in the upper end of the range taught by Seto et al. would have been obvious as well (see instant claims 21, 33-35, and 38-39). Garg et al. are not explicit about how much time prior to intercourse the composition should be applied. However, the juxtaposition of the emphasis on post-intercourse application being “as soon as possible” as well as the guidance to apply the composition within 15 minutes or within one hour after intercourse coupled with the lack of such emphasis on timing for prior-intercourse application suggests more flexibility when the composition may be applied prior to intercourse. In light of the mechanism of action of the composition, application in relatively close proximity to intercourse to ensure vaginal adherence as well as minimal leakage and dilution would have been obvious, therefore application 15 minutes or one hour prior to intercourse, as is taught for post-intercourse application, would have been obvious to the artisan of ordinary skill (see instant claim 30). The composition rendered obvious by the modified teachings of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition Garg et al. due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Thus claims 21-31 and 33-40 are obvious over Garg et al. in view of Moench et al., Lee et al., Seto et al., and Segeren et al.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Garg et al. in view of Moench et al., Lee et al., Segeren et al., and Seto et al. as applied to claims 21-31 and 33-40 above, and further as evidenced by Iwata (previously cited), Lide et al. (previously cited), Potassium Bitartarate MSDS (previously cited), Auras et al. (previously cited), Glycerine reference (previously cited), Xanthan Gum MSDS (previously cited), and Citric Acid MSDS (previously cited).
Garg et al. in view of Moench et al., Lee et al., Segeren et al., and Seto et al. render obvious the limitations of instant claims 21-31 and 33-40 where a formulation with the following composition is employed: 4.25% alginic acid (r = 1.016 g/ml), 3% xanthan gum ((r = 0.75 g/ml), 8% glycerol (r = 1.26 g/ml), 2% L-lactic acid (r = 1.2 g/ml), 1% citric acid (r = 1. 76 g/ml), 0.4% potassium bitartrate (r = 1.25 g/ml) 0.2% benzoic acid (r = 1.26 g/ml), 0 to 10% nonoxynol-9, and water (r = 1 g/ml ) (see example 1; evidentiary references). They additionally teach administration of 5ml of the composition to women (see example 8). In light of the densities of the ingredients, a 5ml dose corresponds to 5g in mass (see instant claim 32). Therefore claim 21-40 are obvious over Garg et al. in view of Moench et al., Lee et al., Segeren et al., and Seto et al. as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Claims 21-31 and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Garg et al. in view of Moench et al., Lee et al. Seto et al., and Fukui et al. (previously cited).
Garg et al. teach a method of preventing pregnancy via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25; instant claim 21). The composition is applied within the vagina (intravaginal application) prior to or as soon as possible after sexual activity, where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36; instant claims 21, 29, and 30). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours(see column 5 line 65-column 6 line 5). As a consequence, Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some sexually transmitted disease (STD) microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent and has a preferred molecular weight of 20,000 to 250,000 g/mol (see column 11 lines 12-18; instant claims 21, 31, and 40). The alginic acid forms a matrix due to interactions with divalent cations in seminal fluid that are not present in the vaginal fluid (see column 11 lines 21-23). The bioadhesive agent is envisioned as xanthan gum as well as hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose (see column 11 lines 42-46; instant claim 25). An example is provided with 4.25% alginic acid, 3% xanthan gum (bioadhesive agent), 8% glycerol (thickener/humectant), 2% lactic acid (buffering agent), 1% citric acid (buffering agent), 0.4% potassium bitartrate (buffering agent), 0.2% benzoic acid (buffering agent), 0 to 10% nonoxynol-9, and water (see example 1 and example 5 table VI; instant claims 21, 23-28, and 36-37). D-lactic acid is not a recited or required component, therefore racemic mixture also not recited as required (see instant claims 21 and 37). The composition has a pH of 3.5 to 3.6 (see instant claim 22 and 38). Both lactic acid and citric acid are taught as buffering agents in the compositions (see column 11 lines 55-60). Further, Garg et al. detail application whose occurrence is preferably prior to sexual activity; however post-sexual activity application is also contemplated and encouraged to occur as soon as possible after sexual activity, which explicitly include immediately, within fifteen minutes, and within an hour (see column 13 line 59-column 14 line 2; instant claims 29-30). The composition of example 1 also demonstrates the ability to stop sperm motility when undiluted and when diluted (see example 4 and example 10). Garg et al. is silent in regard to the ratio of mannuronate to guluronate in their alginic acid or the enantiomer of the included lactic acid.
Moench et al. teach compositions that comprise L-lactic acid for inactivating pathogens in the female genital tract (see abstract). They further teach that both D-lactic acid and L-lactic acid are products of the native flora of the vagina (see paragraph 3). The average L-lactic acid concentration has been measured at 1.2% and pharmaceuticals seek to mimic the acidic environment to provide a protective environment against sexually transmitted pathogens (see paragraph 4). This and other low molecular weight acid buffers have been employed at concentrations higher than that which occur naturally in order to overcome the ability of the alkalinity of semen to compromise the protective vaginal acidity (see paragraph 4). Moench et al. further teach that compositions with L-lactic acid that are substantially free of D-lactic acid reduce potential epithelial toxicity as compared to D-lactic acid or a racemic mixture of L- and D- lactic acid (see paragraphs 4 and 6). The L-lactic acid was also found to be a highly effective microbicide against sexually transmitted pathogens (see paragraph 7).
Lee et al. teach that the guluronate blocks in alginic acid are responsible for the intermolecular crosslinking due to divalent cations (see page 108 first column first full paragraph). They go on to note that the ratio of mannuronate to guluronate (M/G) is one of several critical factors that affect the physical properties of alginic acid and its hydrogel (see page 108 first column first full paragraph).
Seto et al. teach an alginic acid based composition that is envisioned for application to skin or mucosa (see abstract). They go on to teach the composition for vaginal application (see paragraph 16). Seto et al. further teach that the M/G ratio is not particularly limited; however the smaller the value the faster the onset of gelation which is a desired outcome for Seto et al. (see paragraph 63). They point to a most preferred range of 1 or less where lower values are preferred so as to improve retention at the application site (see paragraph 63).
Fukui et al. teach an alginic acid based composition that quickly builds in viscosity upon contact with the application site and is envisioned for application to various tissues including vaginal (see paragraphs 8, 23, and 29-30). They go on to teach the composition for vaginal application (see paragraph 30). Fukui et al. further teach that the M/G ratio is preferably 1 or less; with lower values being preferred because the lower the M/G ratio the greater viscosity enhancing power of the alginic acid (see paragraph 16). A desirable example of alginic acid has an M/G ratio of 0.8 (about 0.7) (see paragraphs 38 and 41; instant claims 21, 33-35 and 38-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the direction of Garg et al. and practice their method of contraception and STD infection inhibition with an exemplified composition. It also would have been obvious to include xanthan gum alone or in combination with another bioadhesive agent because “[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 used 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) (see MPEP 2144.06). Given the teachings of Moench et al. of the epithelial toxicity that occurs due to the presence of D-lactic acid and the benefits of L-lactic acid, it would have been obvious to one of ordinary skill in the art at the time of the invention to select the L enantiomer for the lactic acid and exclude the D-enantiomer of lactic acid (e.g., a ‘purified’ L-lactic acid). Since the premise of the functionality of the composition of Garg et al. is based upon the divalent cations from seminal fluid crosslinking the alginic acid and the responsibility for this functionality lies with the guluronate, it also would have been obvious to select an alginic acid with more guluronate than mannuronate units. Specifically, the selection of the alginic acid of Fukui et al. with an M/G ratio of 0.8 would have been obvious as a particular known variety of this compound that facilitates the premise of functionality of the composition of Garg et al. This choice would have also been obvious because Seto et al. highlights those varieties with an M/G ratio that is less than one as being preferred so as to gel quickly and be retained at a mucosal application site, such as the vagina. The ratio of 0.8 meets the limitations of “about 0.7” as well as the instantly claimed ranges of M/G ratios. Garg et al. are not explicit about how much time prior to intercourse the composition should be applied. However, the juxtaposition of the emphasis on post-intercourse application being “as soon as possible” as well as the guidance to apply the composition within 15 minutes or within one hour after intercourse coupled with the lack of such emphasis on timing for prior-intercourse application suggests more flexibility when the composition may be applied prior to intercourse. In light of the mechanism of action of the composition, application in relatively close proximity to intercourse to ensure vaginal adherence as well as minimal leakage and dilution would have been obvious, therefore application 15 minutes or one hour prior to intercourse, as is taught for post-intercourse application, would have been obvious to the artisan of ordinary skill (see instant claim 30). The composition rendered obvious by the modified teachings of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition Garg et al. due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Thus claims 21-31 and 33-40 are obvious over Garg et al. in view of Moench et al., Lee et al., Seto et al., and Fukui et al.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Garg et al. in view of Moench et al., Lee et al., Seto et al., and Fukui et al. as applied to claims 30, 37-46, 48-51, 56-57, and 59 above, and further as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Garg et al. in view of Moench et al., Lee et al., Seto et al., and Fukui et al. render obvious the limitations of instant claims 21-31 and 33-40 where a formulation with the following composition is employed: 4.25% alginic acid (r = 1.016 g/ml), 3% xanthan gum ((r = 0.75 g/ml), 8% glycerol (r = 1.26 g/ml), 2% L-lactic acid (r = 1.2 g/ml), 1% citric acid (r = 1. 76 g/ml), 0.4% potassium bitartrate (r = 1.25 g/ml) 0.2% benzoic acid (r = 1.26 g/ml), 0 to 10% nonoxynol-9, and water (r = 1 g/ml ) (see example 1; evidentiary references). They additionally teach administration of 5ml of the composition to women (see example 8). In light of the densities of the ingredients, a 5ml dose corresponds to 5g in mass (see instant claim 32). Therefore claims 21-40 are obvious over Garg et al. in view of Moench et al., Lee et al., Seto et al., and Fukui et al. as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-31 and 33-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,566,232 in view of Garg et al., Lee et al., and Fukui et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of intravaginally administering a composition composed of the same proportions of alginic acid, L-lactic acid (e.g., a ‘purified’ L-lactic acid), and a bioadhesive compound. The claims recite the same bioadhesive compounds and further include citric acid, benzoic acid, glycerol, potassium bitartrate and water. An overlapping set of bioadhesive compounds is recited by the instant and the patented claims. Xanthan gum, hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose are recited amongst the bioadhesive compounds of the patented claims. Additionally, the compositions are essentially free of D-lactic acid which embraces freedom form a racemic mixture. The patented claims do not detail the M/G ratio of the alginic acid, the pH of the composition, or details of when it is administered.
Garg et al. teach a method of preventing pregnancy and reducing the risk of transmitting sexually transmitted infections via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25). The composition is applied within the vagina (topical application) prior to or as soon as possible after sexual activity where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours; thus Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some STD microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent and has a preferred molecular weight of 20,000 to 250,000 g/mol (see column 11 lines 12-18). The alginic acid forms a matrix due to interactions with divalent cations in seminal fluid that are not present in the vaginal fluid (see column 11 lines 21-23). An example is provided with 4.25% alginic acid, 3% xanthan gum (bioadhesive agent), 8% glycerol (thickener/humectant), 2% lactic acid (buffering agent), 1% citric acid (buffering agent), 0.4% potassium bitartrate (buffering agent), 0.2% benzoic acid (buffering agent), 0p to 10% nonoxynol-9, and water (see example 1 and example 5 table VI). The composition has a pH of 3.5 to 3.6. Application to the vagina prior to intercourse is taught (see column 5 lines 27-30). Further, Garg et al. detail application that is preferred prior to sexual activity; however post-sexual activity application is also contemplated and encouraged to occur as soon as possible after sexual activity, which explicitly include immediately, within fifteen minutes, and within an hour (see column 13 line 59-column 14 line 2).
Lee et al. teach that the guluronate blocks in alginic acid are responsible for the intermolecular crosslinking due to divalent cations (see page 108 first column first full paragraph). They go on to note that the ratio of mannuronate to guluronate is one of several critical factors that affect the physical properties of alginic acid and its hydrogel (see page 108 first column first full paragraph).
Fukui et al. teach an alginic acid based composition that quickly builds in viscosity upon contact with the application site and is envisioned for application to various tissues including vaginal (see paragraphs 8, 23, and 29-30). They go on to teach the composition for vaginal application (see paragraph 30). Fukui et al. further teach that the M/G ratio is preferably 1 or less; with lower values being preferred because the lower the M/G ratio the greater viscosity enhancing power of the alginic acid (see paragraph 16). A desirable example of alginic acid has an M/G ratio of 0.8 (about 0.7) (see paragraphs 38 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include xanthan gum alone or in combination with another bioadhesive agent because “[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 used 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) (see MPEP 2144.06). It also would have been obvious to select an alginic acid with a molecular weight as taught by Garg et al. and with an M/G ratio of 1 or less for the method of the patented claims. Although the preamble of the patented claims and that of the instant claims detail different outcomes, the same patient population is employed by both and the composition in both instances is effective to yield both outcomes as detailed by Garg et al. Since the premise of the functionality of the patent compositions that are structured much the same as that of Garg et al. which are based upon the divalent cations from seminal fluid crosslinking the alginic acid and the responsibility for this functionality lies with the guluronate, it also would have been obvious to select a variety that is dominated by G subunits. This choice also would have been obvious because it is highlighted by Fukui et al. as being preferred for compositions that are envisioned for application to the vagina. The “1 or less” range of Fukui et al. overlaps with the claimed range (see MPEP 2144.05). There is no evidence of the criticality of the claimed range, therefore the overlapping range of Fukui et al. renders the claimed ranges obvious. It additionally would have been obvious to select an alginic acid with a M/G ratio of 0.8 since it is exemplified by Fukui et al. as being particularly useful for compositions intended to be retained at an application site due to contact with the tissue and its associated fluids. The ratio of 0.8 meets the limitations of “about 0.7”. It further would have been obvious to adjust the pH as taught by Garg et al. in order to maintain vaginal pH. The selection of component proportions as detailed by Garg et al. would also follow. Additionally, application of the composition at the times detailed by Garg et al. also would have been obvious since the compositions are envisioned for use in much the same capacity. Garg et al. are not explicit about how much time prior to intercourse the composition should be applied. However, the juxtaposition of the emphasis on post-intercourse application being “as soon as possible” as well as the guidance to apply the composition within 15 minutes or within one hour after intercourse coupled with the lack of such emphasis on timing for prior-intercourse application suggests more flexibility when the composition may be applied prior to intercourse. In light of the mechanism of action of the composition, application in relatively close proximity to intercourse to ensure vaginal adherence as well as minimal leakage and dilution would have been obvious, therefore application 15 minutes or one hour prior to intercourse, as is taught for post-intercourse application, would have been obvious to the artisan of ordinary skill. The composition rendered obvious by the modified teachings of the patented claims in light of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition of the patented claims due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Therefore claims 21-31 and 33-40 are obvious over claims 1-15 of U.S. Patent No. 9,566,232 in view of Garg et al., Lee et al., and Fukui et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,566,232 in view of Garg et al., Lee et al., and Fukui et al. as applied to claims 21-31 and 33-40 above, and further as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Claims 1-15 of U.S. Patent No. 9,566,232 in view of Garg et al., Lee et al., and Fukui et al. render obvious the limitations of instant claims 21-31 and 33-40 where a formulation with the following composition is employed: 4.25% alginic acid (r = 1.016 g/ml), 3% xanthan gum ((r = 0.75 g/ml), 8% glycerol (r = 1.26 g/ml), 2% lactic acid (r = 1.2 g/ml), 1% citric acid (r = 1. 76 g/ml), 0.4% potassium bitartrate (r = 1.25 g/ml) 0.2% benzoic acid (r = 1.26 g/ml), 0 to 10% nonoxynol-9, and water (r = 1 g/ml) because this embodiment of Garg et al. is embraced by the patented claims (see Garg et al. example 1; evidentiary references). Garg et al. additionally teach administration of 5ml of the composition to women (see example 8). In light of the densities of the ingredients, a 5ml dose corresponds to 5g in mass. Therefore claim 47 is obvious over claims 1-15 of U.S. Patent No. 9,566,232 in view of Garg et al., Lee et al., and Fukui et al. as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Claims 21-31 and 33-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,568,855 in view of Garg et al., Lee et al., and Fukui et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of intravaginally administering a composition composed of the same or embraced proportions of alginic acid, L-lactic acid (e.g., a ‘purified’ L-lactic acid), and a bioadhesive compound, thereby rendering the claimed ranges obvious (see MPEP 2144.05). The claims recite the same bioadhesive compounds and further include the same preservatives and water. The instantly claimed buffering agents overlap with the preservative agents of the patented claims as do the recitation of pH values. Citric acid, potassium bitartrate and benzoic acid are all recited as components of the composition. Xanthan gum, hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose are recited amongst the bioadhesive compounds of the patented claims. The claimed pH range and molecular weight of alginic acid are obvious due their overlap with the claimed ranges (see MPEP 2144.05). The patented claims also recite the application of a composition that includes water which meets the instant limitations for a pharmaceutically acceptable vehicle. Additionally, the compositions are essentially free of D-lactic acid which embraces freedom from racemic mixtures and are recited to function in the same way upon contact with ejaculate. The patented claims do not detail the M/G ratio of the alginic acid or details of when it is administered.
Garg et al. teach a method of preventing pregnancy reducing the risk of transmitting sexually transmitted infections via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25). The composition is applied within the vagina (topical application) prior to or as soon as possible after sexual activity where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours; thus Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some STD microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent (see column 11 lines 12-18). The alginic acid forms a matrix due to interactions with divalent cations in seminal fluid that are not present in the vaginal fluid (see column 11 lines 21-23). An example is provided with 4.25% alginic acid, 3% xanthan gum (bioadhesive agent), 8% glycerol (thickener/humectant), 2% lactic acid (buffering agent), 1% citric acid (buffering agent), 0.4% potassium bitartrate (buffering agent), 0.2% benzoic acid (buffering agent), 0 to 10% nonoxynol-9, and water (see example 1 and example 5 table VI). The composition has a pH of 3.5 to 3.6. Application to the vagina prior to intercourse is taught (see column 5 lines 27-30). Further, Garg et al. detail application that is preferred prior to sexual activity; however post-sexual activity application is also contemplated and encouraged to occur as soon as possible after sexual activity, which explicitly include immediately, within fifteen minutes, and within an hour (see column 13 line 59-column 14 line 2).
Lee et al. teach that the guluronate blocks in alginic acid are responsible for the intermolecular crosslinking due to divalent cations (see page 108 first column first full paragraph). They go on to note that the ratio of mannuronate to guluronate is one of several critical factors that affect the physical properties of alginic acid and its hydrogel (see page 108 first column first full paragraph).
Fukui et al. teach an alginic acid based composition that quickly builds in viscosity upon contact with the application site and is envisioned for application to various tissues including vaginal (see paragraphs 8, 23, and 29-30). They go on to teach the composition for vaginal application (see paragraph 30). Fukui et al. further teach that the M/G ratio is preferably 1 or less; with lower values being preferred because the lower the M/G ratio the greater viscosity enhancing power of the alginic acid (see paragraph 16). A desirable example of alginic acid has an M/G ratio of 0.8 (about 0.7) (see paragraphs 38 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include xanthan gum alone or in combination with another bioadhesive agent because “[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 used 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) (see MPEP 2144.06). It also would have been obvious to select an alginic acid with an M/G ratio of 1 or less for the method of the patented claims. Since the premise of the functionality of Garg et al. composition which is structured the same as that of the patented claims, is based upon the divalent cations from seminal fluid crosslinking the alginic acid and the responsibility for this functionality lies with the guluronate, it also would have been obvious to select a variety that is dominated by G subunits. This choice also would have been obvious because it is highlighted by Fukui et al. as being preferred for compositions that are envisioned for application to the vagina. The “1 or less” range of Fukui et al. overlaps with the claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). There is no evidence of the criticality of the claimed range, therefore the overlapping range of Fukui et al. renders the claimed ranges obvious. It additionally would have been obvious to select an alginic acid with a M/G ratio of 0.8 since it is exemplified by Fukui et al. as being particularly useful for compositions intended to be retained at an application site due to contact with the tissue and its associated fluids. The ratio of 0.8 meets the limitations of “about 0.7”. It further would have been obvious to adjust the pH as taught by Garg et al. in order to maintain vaginal pH. The inclusion of glycerol as a thickener/humectant, citric acid as a buffering agent, potassium bitartrate as a buffering agent, and benzoic acid as a buffering agent) would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and because the majority of them being recited by the patented claims. The selection of component proportions as detailed by Garg et al. would also follow. Additionally, application of the composition at the times detailed by Garg et al. also would have been obvious since the compositions are envisioned for use in much the same capacity. Garg et al. are not explicit about how much time prior to intercourse the composition should be applied. However, the juxtaposition of the emphasis on post-intercourse application being “as soon as possible” as well as the guidance to apply the composition within 15 minutes or within one hour after intercourse coupled with the lack of such emphasis on timing for prior-intercourse application suggests more flexibility when the composition may be applied prior to intercourse. In light of the mechanism of action of the composition, application in relatively close proximity to intercourse to ensure vaginal adherence as well as minimal leakage and dilution would have been obvious, therefore application 15 minutes or one hour prior to intercourse, as is taught for post-intercourse application, would have been obvious to the artisan of ordinary skill. The composition rendered obvious by the modified teachings of the patented claims in light of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition of the patented claims due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Therefore claims 21-31 and 33-40 are obvious over claims 1-29 of U.S. Patent No. 10,568,855 in view of Garg et al., Lee et al., and Fukui et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,568,855 in view of Garg et al., Lee et al., and Fukui et al. as applied to claims 21-31 and 33-40 above, and further as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Claims 1-29 of U.S. Patent No. 10,568,855 in view of Garg et al., Lee et al., and Fukui et al. render obvious the limitations of instant claims 21-31 and 33-40 where a formulation with the following composition is employed: 4.25% alginic acid (r = 1.016 g/ml), 3% xanthan gum ((r = 0.75 g/ml), 8% glycerol (r = 1.26 g/ml), 2% L-lactic acid (r = 1.2 g/ml), 1% citric acid (r = 1. 76 g/ml), 0.4% potassium bitartrate (r = 1.25 g/ml) 0.2% benzoic acid (r = 1.26 g/ml), 0 to 10% nonoxynol-9, and water (r = 1 g/ml) because this embodiment of Garg et al. is embraced by the patented claims (see Garg et al. example 1; evidentiary references). Garg et al. additionally teach administration of 5ml of the composition to women (see example 8). In light of the densities of the ingredients, a 5ml dose corresponds to 5g in mass. Therefore claims 21-40 are obvious over claims 1-29 of U.S. Patent No. 10,568,855 in view of Garg et al., Lee et al., and Fukui et al. as evidenced by Iwata, Lide et al., Potassium Bitartarate MSDS, Auras et al., Glycerine reference, Xanthan Gum MSDS, and Citric Acid MSDS.
Claims 21-30 and 32-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,337,989.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of intravaginally administering a composition composed of the same proportions of alginic acid, L-lactic acid (e.g., a ‘purified’ L-lactic acid), xanthan gum and a bioadhesive compound. The M/G ratio is the same as that instantly claimed as is the dosing amount and application time. The claims recite the same buffers, preservatives, and pH values. Recited thickeners include hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose. Further recitations detail the composition to consist essentially of about 3.5-4.5% alginic acid, about 2.5-3.5% of xanthan gum, about 1-4% L-lactic acid, citric acid, potassium bitartrate, glycerin, benzoic acid, and water. The patented claims also recite the application of the composition that includes the same a pharmaceutically acceptable vehicles. Additionally, the patented compositions are essentially free of D-lactic acid which embraces freedom from racemic mixtures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of the patented claims because they state to do so. The composition recited by the patented claims includes all the claimed components at the claimed proportions. While the prior art does not speak to each aspect of the improved performance of the composition of the patented claims due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the patented composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Therefore claims 21-30 and 32-39 are obvious over claims 1-19 of U.S. Patent No. 11,337,989
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,337,989, as applied to claims 21-30 and 32-39 and further in view of Garg et al.
Claims 1-19 of U.S. Patent No. 11,337,989 render obvious the limitations of instant claims 21-31 and 33-40. The molecular weight of the alginic acid is not recited.
Garg et al. teach a method of preventing pregnancy reducing the risk of transmitting sexually transmitted infections via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25). The composition is applied within the vagina (topical application) prior to or as soon as possible after sexual activity where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours; thus Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some STD microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent and has a preferred molecular weight of 20,000 to 250,000 g/mol (see column 11 lines 12-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the preferred alginic acid molecular weight to Garg et al. in the patented method because it was preferable in the composition is structured similarly and employed for the same purpose. The selection of component proportions as detailed by Garg et al. would also follow. The composition rendered obvious by the modified teachings of the patented claims in light of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition of the patented claims due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Therefore claims 21-40 are obvious over claims 1-19 of U.S. Patent No. 11,337,989 in view of Garg et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,992,472 in view of Garg et al., Lee et al., and Fukui et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of intravaginally administering a composition to prevent pregnancy composed of the same or embraced proportions of alginic acid, L-lactic acid, and a bioadhesive compound, thereby rendering the claimed ranges obvious (see MPEP 2144.05). The claims recite the same bioadhesive compounds and further include the same preservatives and water. The instantly claimed buffering agents overlap with the preservative agents of the patented claims as do the recitation of pH values. Citric acid, potassium bitartrate and benzoic acid are all recited as components of the composition. Xanthan gum, hydroxypropyl cellulose, chitosan, and sodium carboxymethyl cellulose are recited amongst the bioadhesive compounds of the patented claims. The claimed pH range, application amounts and molecular weight range for the alginic acid are obvious due their overlap with the claimed range (see MPEP 2144.05). The patented claims also recite the application of a composition that includes water which meets the instant limitations for a pharmaceutically acceptable vehicle. Additionally, the total lactic acid in the composition is not a racemic mixture. The patented claims do not detail the M/G ratio of the alginic acid or details of when it is administered.
Garg et al. teach a method of preventing pregnancy reducing the risk of transmitting sexually transmitted infections via the application of an antimicrobial and contraceptive composition (see column 5 lines 15-25). The composition is applied within the vagina (topical application) prior to or as soon as possible after sexual activity where it forms a semisolid upon contact with semen ejaculated into the vagina (see column 5 lines 27-36). Additionally, vaginal pH increases from about 4 under normal conditions to about 6 to 7 shortly after ejaculation following unprotected sex and remains high for 2 to 8 hours; thus Garg et al. teach reestablishing or maintaining acidic pH to assist in killing, inactivating, or immobilizing some STD microbes and spermatozoa in the vagina (see column 5 line 65-column 6 line 5). The composition of Garg et al. is about 1 to about 10% matrix forming agent, about 1 to about 10% bioadhesive agent, about 1 to about 10% buffering agent, and water (see column 6 lines 55-61 and column 10 lines 57-61). Alginic acid is the preferred matrix forming agent (see column 11 lines 12-18). The alginic acid forms a matrix due to interactions with divalent cations in seminal fluid that are not present in the vaginal fluid (see column 11 lines 21-23). An example is provided with 4.25% alginic acid, 3% xanthan gum (bioadhesive agent), 8% glycerol (thickener/humectant), 2% lactic acid (buffering agent), 1% citric acid (buffering agent), 0.4% potassium bitartrate (buffering agent), 0.2% benzoic acid (buffering agent), 0 to 10% nonoxynol-9, and water (see example 1 and example 5 table VI). The composition has a pH of 3.5 to 3.6. Application to the vagina prior to intercourse is taught (see column 5 lines 27-30). Further, Garg et al. detail application that is preferred prior to sexual activity; however post-sexual activity application is also contemplated and encouraged to occur as soon as possible after sexual activity, which explicitly include immediately, within fifteen minutes, and within an hour (see column 13 line 59-column 14 line 2).
Lee et al. teach that the guluronate blocks in alginic acid are responsible for the intermolecular crosslinking due to divalent cations (see page 108 first column first full paragraph). They go on to note that the ratio of mannuronate to guluronate is one of several critical factors that affect the physical properties of alginic acid and its hydrogel (see page 108 first column first full paragraph).
Fukui et al. teach an alginic acid based composition that quickly builds in viscosity upon contact with the application site and is envisioned for application to various tissues including vaginal (see paragraphs 8, 23, and 29-30). They go on to teach the composition for vaginal application (see paragraph 30). Fukui et al. further teach that the M/G ratio is preferably 1 or less; with lower values being preferred because the lower the M/G ratio the greater viscosity enhancing power of the alginic acid (see paragraph 16). A desirable example of alginic acid has an M/G ratio of 0.8 (about 0.7) (see paragraphs 38 and 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include xanthan gum alone or in combination with another bioadhesive agent because “[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 used 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) (see MPEP 2144.06). It also would have been obvious to select an alginic acid with an M/G ratio of 1 or less for the method of the patented claims. Since the premise of the functionality of Garg et al. composition which is structured the same as that of the patented claims, is based upon the divalent cations from seminal fluid crosslinking the alginic acid and the responsibility for this functionality lies with the guluronate, it also would have been obvious to select a variety that is dominated by G subunits. This choice also would have been obvious because it is highlighted by Fukui et al. as being preferred for compositions that are envisioned for application to the vagina. The “1 or less” range of Fukui et al. overlaps with the claimed range; thereby rendering the instantly claimed range obvious (see MPEP 2144.05). There is no evidence of the criticality of the claimed range, therefore the overlapping range of Fukui et al. renders the claimed ranges obvious. It additionally would have been obvious to select an alginic acid with a M/G ratio of 0.8 since it is exemplified by Fukui et al. as being particularly useful for compositions intended to be retained at an application site due to contact with the tissue and its associated fluids. The ratio of 0.8 meets the limitations of “about 0.7”. It further would have been obvious to adjust the pH as taught by Garg et al. in order to maintain vaginal pH. The inclusion of glycerol as a thickener/humectant, citric acid as a buffering agent, potassium bitartrate as a buffering agent, and benzoic acid as a buffering agent) would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and because the majority of them being recited by the patented claims. The selection of component proportions as detailed by Garg et al. would also follow. Additionally, application of the composition at the times detailed by Garg et al. also would have been obvious since the compositions are envisioned for use in much the same capacity. Garg et al. are not explicit about how much time prior to intercourse the composition should be applied. However, the juxtaposition of the emphasis on post-intercourse application being “as soon as possible” as well as the guidance to apply the composition within 15 minutes or within one hour after intercourse coupled with the lack of such emphasis on timing for prior-intercourse application suggests more flexibility when the composition may be applied prior to intercourse. In light of the mechanism of action of the composition, application in relatively close proximity to intercourse to ensure vaginal adherence as well as minimal leakage and dilution would have been obvious, therefore application 15 minutes or one hour prior to intercourse, as is taught for post-intercourse application, would have been obvious to the artisan of ordinary skill. The composition rendered obvious by the modified teachings of the patented claims in light of Garg et al. includes all the claimed components at the claimed proportions and more specifically contains 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. While the prior art does not speak to each aspect of the improved performance of the composition of the patented claims due to the modifications set forth above, MPEP 2145II details that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition to meeting the structural limitations the claim, the composition is nearly the same as a tested embodiment described by Rothmann in the declarations filed February 23, 2026 that has the claimed functionality. The composition rendered obvious appears to differ from that tested by declarant Rothmann that has the claimed functionality only in terms of the concentration of L-lactic acid, where Rothmann includes a 1.8 wt%. This corresponds to a rather small 11% difference in the proportion of this component which is unlikely to negate the functionality demonstrated by Rothmann. Thus the modified composition is sufficient to meet the instant limitations concerning reducing sperm motility upon mixture with semen at a 1:6. Therefore claims 21-40 are obvious over claims 1-18 of U.S. Patent No. 11,992,472 in view of Garg et al., Lee et al., and Fukui et al.
Declaration
The declarations under 37 CFR 1.132 filed February 23, 2026 is insufficient to overcome the rejection of claims 21-40 based upon Garg et al. in view of others as set forth in the last Office action because: the claim are not commensurate in scope with the showing.
The claims are drawn to a method of administering a composition that comprises about 1-4% L-lactic acid that is purified L-lactic acid or produced by a recombinant yeast or bacterium…wherein the total lactic acid in the composition is not in a form of racemic mixture”. A racemic mixture is equal amounts of the L and D enantiomer of a compound (see Allen, R. E. (Ed.). (2007). Racemic. In The Penguin English Dictionary (3rd ed.). Penguin). Thus the claim recitation permits the presence of D-lactic acid so long as it is not present at an equal amount relative to L-lactic acid that is also present. The declarations by Rothmann focus on the capabilities of compositions with L-lactic acid in the absence of D-lactic acid as compared to those with lactic acid having an unspecified enantiomer distribution. As noted in MPEP 716.02(d” “[w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support”. Here the claimed method does not apply a composition whose lactic acid is limited to or mostly L-lactic acid. Therefore any improvement due to a predominance of the L enantiomer of lactic acid in a composition is not present throughout the claim scope because the claim scope permits the presence of D-lactic acid at proportions other than those that are equal to that of the L-enantiomer of lactic acid that is also present.
The declaration by Moench argues that the inclusion of L-lactic acid and the exclusion of D-lactic would not have been expected to reduce sperm motility so effectively because sperm cells have the ability to metabolize the L enantiomer and not the D enantiomer. While this expectation may be true, it is not sufficient by itself to override the teaching that supports the superiority of the L enantiomer over the D enantiomer in regard to STD inhibition and toxicity avoidance. According to MPEP 2144 IV, “[t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).”
Declarant Moench argues that L-lactic may be expected to perform stronger in one of its properties (antimicrobial efficacy) than another (contraception) as compared to a racemic mixture at an application site due to the lower human cell toxicity of L-lactic acid as compared to D-lactic acid. It is not clear that toxicity on epithelial cells, as was assessed by the work of Moench et al. (see example 7) referenced by declarant Moench, is instructive regarding sperm toxicity and mobility. The discussion of declarant Moench provides a tendency toward including the D lactic acid enantiomer, but the suggestion is not sufficient to overcome the motivation provided by Moench et al. to explicitly include L-lactic acid in the composition of Garg et al. that is both antimicrobial and contraceptive due to its superior antimicrobial properties over other enantiomers.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed February 23,2026 have been fully considered but they are not persuasive.
Regarding rejections under 35 USC 103 and the applicant’s comments concerning claims 21 and 37
The applicant argues that the discussion of disclosed compositions “trapping” sperm or “preventing or greatly decreasing their migration through and out of the lower genital tract” are discussions of the capabilities of the recited composition when present at a 1:6 ratio with semen. There is no discussion of any dilution ratio of the composition relative to semen when in the lower genital tract such that it could be relied upon to support the claimed ratio. In addition, there is no discussion of a testing ratio of the instant composition relative to semen with which it is combined or the resulting impact on sperm motility. Thus contrary to the applicant’s argument, there is no reason for the artisan of ordinary skill to understand that the applicant was in possession of a composition with the specific functionality that is now claimed (the intravaginal composition reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6) based on the discussion in the disclosure as filed.
The applicant goes on to quote portions of the declarations provided by Rothmann which appear to be the source of the new limitations. The declarant explored particular functionalities of the claimed composition that were not discussed in the disclosure in effort to show the claimed invention to be non-obvious. While such evidence can be useful in the determination of obviousness, it cannot serve as the source for limitations imported into the claims when the disclosure does not discuss these aspects in the declaration with the same degree of specificity. Therefore the discussion provided by the disclosure is insufficient to provide written basis for the new claim language stating, “the intravaginal composition reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6”.
In addition, the applicant argues that the rejections over Garg et aI. in view of others do not disclose the limitations of a intravaginal composition that reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6. There is no discussion in the disclosure of the structural features of a intravaginal composition that has this property beyond the components already recited and rendered obvious by Garg et al. in view of others. The rejections render obvious a composition composed of 4.25% alginic acid, 3% xanthan gum, 8% glycerol, 2% L-lactic acid, 1% citric acid, 0.4% potassium bitartrate, 0.2% benzoic acid, and water. This composition appears to differ from that tested by Rothmann and shown to have the claimed functionality only in the concentration of L-lactic acid, here Rothmann includes a 1.8 wt%. This corresponds to an 11% difference in the proportion of this component. It is unlikely, absent some evidence, that such a small difference constitutes a boundary between compositions inside and outside the scope of those that are permissible to employ in the clamed method based on the recited sperm motility functionality. The applicant further argues that the selection of L-lactic acid as the enantiomer of lactic acid yields an unexpectedly superior result via repetition of the data from the declarations; however the claims and the showing are not commensurate in scope, therefore the superior outcome shown in the declaration is not sufficient to demonstrate non-obviousness of the claimed invention.
The applicant argues that the prosecution of the parent application 15/106755 agreed that a composition comprising L-lactic acid is unexpectedly superior to a composition with racemic lactic acid in regard to its impact on sperm motility. The positions set forth the by the examiner in the prior prosecution did not make such a statement or draw this conclusion. Garg et al. is the prior art also relied upon in this prior prosecution. They do not describe their lactic acid as racemic lactic acid, but since they do not specify the lactic acid enantiomer, a mixture of both enantiomers is presumed present. Perhaps more precisely stated, the declaration of Rothmann shows an instant composition with L-lactic acid and (substantially) free of D-lactic acid is superior to what appears to be the same composition with an unspecified enantiomer blend of lactic acid at reducing sperm motility and stabilizing pH in the presence of sperm. The impact of a particular ratio of L to D lactic acid enantiomer on sperm motility was not explored in the declarations or in the instant disclosure. Moench et al., who is cited in the rejection, assessed L, D, and racemic lactic acid in regard to efficacy against genital pathogens and found the L-lactic acid to be superior to both D-lactic acid containing varieties. However this set of comparisons is distinct from those provided by the declarant.
The applicant argues that the contraceptive functionality of L-lactic acid was not adequately considered in light of the declaration by Moench. The discussion by declarant Moench was considered, but the conclusions it reaches are not fully supported by evidence and are insufficient to overcome the prior art teachings pointing toward obviousness. There is no evidence of record that the L enantiomer of lactic acid is ineffective as a contraceptive. A connection between the epithelial cell viability assessed after treatment with various lactic acid enantiomer forms in Moench et al. and sperm viability after treatment with lactic acid was not provided such that the conclusion by Moench in the declaration is supported by the record. Thus it is not evident that the artisan of ordinary skill would presume L-lactic having low epithelial cell toxicity would also yield low sperm toxicity and a correspondingly low impact on sperm motility such that it would be deemed inadequate as a part of the contraceptive of Garg et al. The discussion of Moench in the declaration raises possibilities for a preference toward D-lactic acid due to a potentially low impact on sperm motility and a higher metabolic rate for L-lactic acid, but none are provided with evidence that outweighs the evidence of L-lactic acid superiority over D-lactic acid in regard to its function as an antimicrobial compound effective against genital microbes and the benefit gleaned from the L enantiomer when choosing a lactic acid enantiomer for the utility desired by Garg et al.
The applicant appears to also argue that the findings of low epithelial toxicity of L-lactic acid by Moench et al. would not have been deemed applicable to vaginal epithelial cells because the claimed L-lactic acid concentration is within the physiological concentration range. The applicant then concludes that the teaching of Moench et al. would not support the modification of lactic acid concentration. This argument is not relevant to the rejections because the rejections do not modify the concentration of lactic acid based upon Moench et al.
The applicant further argues that Garg et al. teach the optional inclusion of additional antimicrobial compounds and thus there is no reason to substitute L-lactic acid for racemic lactic acid toward this end. To be clear, Garg et al. do not state that their lactic acid is a racemic mixture. They provide no discussion of its enantiomeric composition. Given the stated use of the composition of Garg et al., it would certainly have been obvious for the artisan to select a lactic acid form that carries its own antimicrobial properties against relevant microbes. The fact that Garg et al. detail additional antimicrobial actives beyond the recited base composition components being present in no way limits the properties conferred by the base composition components. Further, even if Garg et al. did not contemplate individual components of the base composition providing antimicrobial properties, “[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 used 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) (see MPEP 2144.06). Thus the selection of antimicrobial versions of the Garg et al. composition components also would have been obvious on this basis.
Regarding the Double Patenting rejections:
The applicant argues that the rejection over US Patent 9,566,232 is directed to a method of reducing the risk of sexually transmitted infections which is not the instantly claimed prevention of conception. As the rejection notes, the modified patented claims apply a claimed composition in the same way, to the same patient population, under the same conditions as that instantly claimed. Further, Garg et al., who is relied upon in the rejection, shows that compositions constituted with nearly the same combination of components can function as both a contraceptive and inhibitor of infection. Thus in addition to contraception potentially occurring inadvertently along with infection inhibition, it would have been obvious to purposefully apply the composition for the purpose of performing both functions.
The applicant argues that the instant claims are non-obvious over the claims of US Patent No. 10,568,855 , 11,337,989, and 11,992,472 because they do not recite an intravaginal composition that reduces a motility of sperm to 0% in a mixture of the intravaginal composition and semen at a ratio of 1:6. The issues concerning the undefined scope of such compositions are addressed above as is the proximity of the compositions administered in the modified patent claims to that shown by the declarant to have this functionality were addressed in the updated rejections and discussed in the preceding section concerning the rejections under 35 USC 103. This response is also reiterated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615