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 .
Election/Restrictions
The present application remains examined under applicant’s election, without traverse, of Group I (claims 1-10).
Claims 23-24 and 29-36 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-10 are directed to the elected invention and have been examined on their merits.
Amendments
Claim 1 has been amended to remove the “about” limitation in line 7.
Claim 7 has had “about” removed from line 2, has had a “%” symbol added to line 2 and has had the word “optionally” added to line 3.
Claim 8 has had the word “optionally” added to line 2.
Claims 23, 29, and 34-35 remain withdrawn and have been amended.
Drawings
Previous objection to the drawings
The drawings were objected to because the drawings were improperly labeled. In response, applicant has filed an amended drawing sheet which corrects this deficiency. Accordingly, the objection to the drawings is withdrawn and the drawings are accepted.
Claim Objections
Previous objection to the claim
Claim 7 was objected to for a minor informality. Applicant has provided the appropriate correction and the objection is therefore withdrawn.
Claim Rejections - 35 USC § 112
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.
Previous rejection under 35 U.S.C. § 112
RE: Rejection of claims 1-10 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint, regards as the invention.
Claims 1-10 were previously rejected as being indefinite. Without acquiescing to the merits of this rejection, applicant has removed the indefinite use of the terms about in claims 1 and 7 and has amended claims 7-8 to clarify which limitations are optional. Accordingly, the rejection under 35 U.S.C. § 112(b) have been withdrawn.
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.
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.
Previous rejection under 35 U.S.C. § 103
Claims 1 and 3-10 were rejected as obvious over Dolmer in view of Sjӧberg. Claims 1-10 were rejected as obvious over Dolmer in view of Sjӧberg and Krzysik. Applicant traverses these rejection by arguing that Sjӧberg does not appropriately remedy the deficiencies of Dolmer.
First, applicant asserts that Sjӧberg provides a storage container including a product sensitive to moisture and oxidation, suspended in a non-water liquid and a strip of desiccant polymer or a desiccant film and this composition was intended as a probiotic for ingestion. Applicant states that this is in contrast to the present invention which is for application to the skin, and which is a solid or semi-solid phase formulation, not a liquid.
Second, applicant argues that although Dolmer teaches a great need to find a way to improve the stability of topical compositions, this problem was solved by Dolmer and a person having ordinary skill in the art would allegedly not have had a reason to turn to Sjӧberg for guidance in order to further improve the composition.
Third, applicant argues that a person having ordinary skill in the art would not have modified Dolmer in view of Sjӧberg because Sjӧberg did not provide suggestion that a desiccant would provide moisture-absorbing properties when used in combination with a solid or semi-solid phase anhydrous base formulation.
Fourth, applicant asserts that Sjӧberg fails to suggest the desiccant polymer is suitable to maintain the viability of a fine grain culture powder of dried probiotic bacteria. In furtherance of this argument, applicant asserts that the effect of the desiccant polymer on the viability of a fine grain culture powder is a surprising benefit as such a fine grain powder is more exposed to moisture than a standard grain powder.
Fifth, applicant statues that the formulation stored in this way remains stable and it was particularly surprising that the formulation maintained its appearance during storage.
Applicant’s arguments have been fully reviewed but are not sufficient to overcome the rejection of record for the following reasons.
With respect to the first argument, although it is appreciated that Sjӧberg’s composition involves a product “suspended in a non-water liquid” (p. 3, lines 32-35; claim 1), that does not mean that Sjӧberg could not provide guidance on how to improve Dolmer’s composition. The plain meaning of “desiccant’ is “a drying agent” (Desiccant. Merriam Webster, https://www.merriam-webster.com/dictionary/desiccant, accessed March 2026). Accordingly, it was well-known that desiccants dry products because that is the plain and well-understood meaning of the term and mechanism of action. Applicant’s specification affirms this conclusion by teaching “the desiccant material is generally known to reduce the moisture content within a package” (Specification, p. 1, lines 26-31).
Sjӧberg’s moisture absorbing material includes polymer strips or a foil having an incorporated chemical desiccant material in a packaging for the storage of freeze-dried lactic acid bacteria formulated with oil or as an internally coating for a container (p. 3, lines 26-31; p. 5, lines 13-14). Notably, Sjӧberg’s desiccant is not physically combined with the non-water liquid (both are simply included in the container) and the desiccating effects of the desiccant would not have been expected to only operate when in a container with a non-water liquid. Accordingly, Sjӧberg’s teaching of the use of a non-water liquid is not sufficient to make it non-combinable with the teachings of Dolmer because the precise purpose is to preclude water from the container and Sjӧberg therefore directly addresses the problems outlined by Dolmer.
With respect to the second argument, the examiner disagrees with the assertion that there would have been no reason for a person of ordinary skill in the art to seek to further improve Dolmer’s composition. Dolmer teaches that it is well known in the art that probiotic bacteria in topical formulations do not survive in formulations that are moist and/or when then formulations are kept at high temperatures (p. 1, lines 4-6). Moreover, Dolmer teaches that there is a need in the art to provide topical formulations comprising viable probiotic bacteria after production, and after storage (p. 2, lines 9-11). Accordingly, although Dolmer provides an improvement in the art, it does not teach away from further improving the composition such as by including a desiccant.
Dolmer teaches throughout its disclosure that the formulation should have limited water (p. 1, lines 21-26; p. 18, lines 26-28; p. 24, lines 10-24; p. 25, line 18 through p. 26, line 7). Thus, a person having ordinary skill in the art would have immediately recognized the usefulness of a desiccant in a container comprising a moisture-sensitive probiotic product when viewing Dolmer and Sjӧberg. And although it is acknowledged that Sjӧberg is directed to ingestible compositions and not topical compositions, the mechanism of action of the desiccant does not change based on the intended use of the composition in the container. In both applications, it would have been reasonably expected that the desiccant would perform its inherent and well-understood function of absorbing moisture in a container, thereby improving the viability and shelf-stability of the container comprising powdered probiotics.
With respect to the third argument, throughout their arguments applicant has asserted that Sjӧberg does not inform the use of desiccants in Dolmer’s composition (or the instantly claimed composition) because Sjӧberg teaches “a non-water liquid” which applicant characterizes as being “mainly an oil” (Remarks, p. 3, par. 3). And although the instant claims differ because the compositions claimed are required to be “solid or semi-solid phase formulations at 25°C”, there is no evidence that desiccants were known to behave differently when used in a container comprising a solid or a semi-solid phase formulation rather than “mainly an oil”. The purpose of the desiccant remains the same. That is, the desiccant precludes moisture from a container comprising a viable probiotic. As such, the examiner disagrees with applicant’s position that a person having ordinary skill in the art would not have expected a desiccant to be functional when combined in a container with a solid or a semi-solid phase formulation rather than a composition that is “mainly an oil”. To accept such a position would require disregarding the plain meaning of the term “desiccant” and the well-understood purpose of desiccants in containers.
With respect to the fourth argument, although it is accepted that including a desiccant with a “fine grain powder” may be more beneficial than with a “standard grain powder” due to the increased amount of surface area (and thus exposure to moisture), the reasons to include a desiccant remains the same. There is no evidence that including a desiccant with a fine grain powder elicits some remarkable or unexpected result. Instead, the desiccant performs its well-understood function. A theoretical change in the extent of viability improvement is not a particularly compelling indication of non-obviousness when the prior art teaches (i) ointments comprising fine grain culture powders of dried viable probiotic bacteria (Dolmer, p. 9, lines 7-11; p. 24, lines 10-21) and (ii) the use of desiccants to improve the viability of products comprising culture powders of dried viable probiotic bacteria (Sjӧberg, p. 3, lines 30-34; p. 5, lines 1-2).
With respect to the fifth argument, in light of the teachings of Dolmer and Sjӧberg, it would have been expected that including a desiccant in a container comprising viable probiotic bacteria would improve the shelf-life, stability, and viability of the composition. As such, it is not unexpected or remarkable to observe a minimization of effects resulting from product degradation or spoilage.
In summary, Dolmer provides for applicant’s entire container except for the inclusion of a solid support comprising a desiccant polymer. For the reasons discussed above and in the rejection of record, it would have been obvious to have included a solid support comprising a desiccant polymer because Sjӧberg teaches such compositions as being useful for improving the viability and stability of containers comprising viable powdered probiotic bacteria which are sensitive to water and moisture.
For at least these reasons, the rejection of record is proper and has been maintained. The text of the rejection has been modified to account for the amendment to claim 1 (removal of the approximation “about”) but the thrust of the rejection remains unchanged.
Maintained but modified rejections under 35 U.S.C. § 103
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dolmer et al. (WO 2020/007931 A1; cited in IDS dated 12/21/2022) in view of Sjӧberg (WO 2012/038414 A1; cited in IDS dated 12/21/2022).
Dolmer et al. (hereinafter Dolmer) teaches that it is well known in the art that probiotic bacteria in topical formulations do not survive in formulations that are moist and/or when then formulations are kept at high temperatures (p. 1, lines 4-6). To this end, Dolmer teaches topical compositions comprising at least 106 CFU/g bacteria of at least one probiotic bacterial strain that remain viable in said composition for at least 6 months at 25°C (p. 1, lines 9-10).
Regarding claim 1, Dolmer teaches “a device” (i.e., a container) comprising a topical composition. The position that Dolmer’s “device” is a “container” is supported by Dolmer’s teachings that the devices can be aluminum tubes with re-attachable screw lids, sachets, ampules, plastic tubes with pump lids, or comprise a housing element and a delivery element (p. 21, lines 12-25). Applicant defines “container” to mean “any type of reservoir, box or carton, tube or the like for storing the ointment composition” (Specification, p. 9, lines 4-6).
With respect to the ointment composition, Dolmer teaches that in preferred embodiments, the topical composition can be an ointment (p. 24, lines 4-7).
With respect to the anhydrous base formulation, Dolmer teaches that the probiotic bacteria are anhydrous or substantially free from water (p. 9, lines 1-5). Moreover, as discussed above, Dolmer teaches that it is well known in the art that probiotic bacteria in topical formulations do not survive in formulations that are moist. Accordingly, although Dolmer doesn’t directly teach an anhydrous base formulation, it would have been obvious for the base formulation to be anhydrous because the presence of moisture or water would have been expected to negatively affect the viability of the probiotic ointment. Additionally, as discussed below, Dolmer teaches the same components recited in the claim and therefore the base formulation is necessarily anhydrous.
With respect to the fine grain culture powder of dried viable probiotic bacteria, Dolmer teaches that the topical composition is provided with dried viable probiotic bacteria (p. 9, lines 7-11). Dolmer defines the “dry composition” as meaning a composition which is powdered and which has a particle size diameter below 500 µm, preferably below 200 µm (i.e., having a particle size distribution of d(90) < 250 µm)(p. 24, lines 10-21). Dolmer teaches that it is preferred to have a particle size of no more than 200 µm in order to provide a pleasant skin feel for the consumer when using the topical composition of the invention (Id.). Thus, Dolmer’s composition is a fine grain culture powder of dried viable probiotic bacteria having a particle size distribution of (d90) < 250 µm.
With respect to the anhydrous base formulation comprising a vegetable fat, a vegetable oil and a hydrogenated vegetable oil, Dolmer teaches that the composition may comprise elements such as vegetable oils (evening primrose oil, grapeseed oil, macadamia oil, olive oil, rice bran oil, safflower oil, sesame oil, soybean oil, sunflower oil, avocado oil; p. 4, lines 12-26; see Specification, p. 18, lines 9-18 for support of this interpretation), vegetable fat (shea nut butter; p. 4, lines 12-26; see Specification, p. 17 through 32 through p. 18, line 7), and hydrogenated vegetable oil (p. 5, line 10).
With respect to the solid support comprising a desiccant polymer, Dolmer does not directly teach that the composition further comprises a solid support comprising a desiccant polymer.
Nonetheless, Sjӧberg teaches that a general problem encountered in the application of freeze-dried microorganism preparations is the limited storage stability of the cells since the available free water content is deleterious for cells (p. 1, lines 16-20). To address this, Sjӧberg teaches a storage container for a product such as a freeze-dried lactic acid bacteria formulated with oil and a storage container including a product sensitive to moisture and oxidation, suspended in a non-water liquid, and a strip of desiccant polymer or desiccant film (p. 3, lines 30-34). Specific embodiments include L. reuteri formulated in oil, with a desiccant film (p. 5, lines 1-2). Sjӧberg’s container with a strip of desiccant polymer is considered to be a solid support comprising a desiccant polymer based upon applicant’s definition of the term “solid support” which teaches that the support can be part of the container per se (Specification, p. 12, lines 15-17).
Because Dolmer teaches the ointment composition comprising an anhydrous base formulation and a fine grain culture powder of dried viable probiotic bacteria having a particle size distribution of less than 200 um (i.e., d(90) < 250 um), wherein said anhydrous base formulation comprises a vegetable oil, a vegetable fat, and/or a hydrogenated vegetable oil and because Sjӧberg teaches a container comprising a solid support comprising a desiccant polymer, which improves the viability of dried probiotic powders in oil, it would have been obvious to have included a solid support comprising a desiccant polymer in Dolmer’s topical composition. There would have been particular motivation to make this modification because the modification would have been expected to improve Dolmer’s composition by reducing water content, especially because Dolmer teaches that that it is well known in the art that probiotic bacteria in topical formulations do not survive in formulations that are moist (p. 1, lines 4-6). Thus, there would have been a reasonable expectation that including Sjӧberg’s desiccant polymer would improve the performance of Dolmer’s probiotic ointment in a container by promoting product stability. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
With respect to the anhydrous base formulation being a solid or a semi-solid phase formulation at 25°C, Dolmer teaches that the composition can be held at 25°C (p. 1, lines 4-10). Because Dolmer’s composition is the same (i.e., Dolmer teaches the same anhydrous base formulation), it must also inherently possess the characteristic of being solid or semi-solid as 25°C. As such, Dolmer teaches an anhydrous base formulation which is a solid or a semi-solid phase formulation as 25°C. Additionally, it is noted that Dolmer teaches that the oils and waxes maybe solid or fluid at room temperature (i.e., 25°C; see, specification p. 9, line 26).
Thus, claim 1 is obvious over Dolmer in view of Sjӧberg.
Regarding claims 3-5, although Dolmer teaches the overall weight percentage of the hydrophobic compounds (such as at least 80% w/w)(p. 12, lines 11-16), it does not teach the specific percent ranges recited in the instant claims.
Nonetheless, a person having ordinary skill in the art when selecting more than one component from Dolmer’s “at least one” compound would have been expected to routinely experiment with various concentrations of each component and could have arrived at the recited ranges with a reasonable expectation of success. Because Dolmer teaches compositions comprising the three elements recited in these claims and the claims differ only in their concentration (i.e., their by-weight percentages), a prima facie case of obviousness exists. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP § 2144.05(II)(A)). As discussed above, it would have been obvious to have arrived at the range through routine experimentation and there is no evidence of record that the recited ranges elicit some unexpected or remarkable result.
Thus, claims 3-5 are obvious over Dolmer in view of Sjӧberg as a result of routine experimentation.
Regarding claim 6, as discussed above, it would have been obvious to have incorporated Sjӧberg’s solid support strip comprising a desiccant polymer (p. 3, lines 30-34). Additionally, Sjӧberg teaches that the product can be used to form a desired shaped article such as a plug type insert and liner (i.e., may be present as a moulding in a packaging material) or may be in the form of a film, a sheet, a bead, or a pellet.
Thus, Dolmer in view of Sjӧberg renders obvious the container wherein said solid support is a strip, a bead, a film, or is present as a moulding in a packaging material of said container.
Regarding claim 7, Dolmer teaches that the probiotic bacteria in the topical composition (i.e., the said ointment) is no more than 20% w/w or at least 0.1% w/w (p. 12, lines 18-27). Thus, Dolmer teaches a range (0.1-20% w/w) which overlaps with the instantly claimed range (0.001 to 10% w/w). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claim 8, Dolmer teaches that the viable bacteria can be selected from any strain belonging to the genus Lactobacillus and/or Bifidobacterium. The claim is to the genus “lactic acid bacteria” and Dolmer teaches species falling within the claimed genus (“Lactobacillus” and “Bifidobacterium”). "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus (MPEP § 2131.02(I)).
As such, Dolmer in view of Sjӧberg makes obvious the container wherein the probiotic bacteria is lactic acid bacteria.
Regarding claim 9, as discussed above, Dolmer teaches a container comprising aluminum tubes with re-attachable screw lids, sachets, ampules (i.e., a glass container), plastic tubes with pump lids, or comprise a housing element and a delivery element (p. 21, lines 12-25).
Regarding claim 10, although neither Dolmer nor Sjӧberg explicitly teach that the container is air-tight, Dolmer nonetheless teaches “air-tight containers”. Applicant teaches that “air-tight” means a container which is “air-tight as far as possible” and that means that it “will prevent air/oxygen and/or moisture from entering the container which may negatively affect the properties of the ointment composition” (Specification, p. 9, lines 14-19). However, “this does not mean that no air/oxygen/moisture at all will enter said container”, “instead, it means that it will be made from a material that aim to prevent air/oxygen/moisture from entering the container and reaching the ointment composition” (Id.).
Thus, because Dolmer teaches containers such tubes with screw lids, ampules, and plastic tubes with pump lids, Dolmer teaches containers which “aim to prevent air/oxygen/moisture from entering the container and reaching the ointment composition”. The position that these components (such as the lids and ampules) “aim to prevent air/oxygen/moisture” is supported by Dolmer’s teaching that it is well known in the art that probiotic bacteria in topical formulations do not survive in formulations that are moist and/or when then formulations are kept at high temperatures (p. 1, lines 4-6) and therefore Dolmer’s containers are clearly intended to maintain a low moisture content.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dolmer et al. (WO 2020/007931 A1; cited in IDS dated 12/21/2022) in view of Sjӧberg (WO 2012/038414 A1; cited in IDS dated 12/21/2022) and Krzysik et al. (US 2005/0058669 A1).
The teachings of Dolmer and Sjӧberg are set forth above and applied herein. Dolmer and Sjӧberg are found to render obvious claims 1 and 3-10.
Regarding claim 2, as discussed above, Dolmer in view of Sjӧberg renders obvious the container of claim 1. As discussed above, Dolmer teaches that the composition may comprise at least one compound selected from a list which comprises shea butter.
Additionally, Dolmer teaches that the composition may comprise vegetable oil and hydrogenated vegetable oil but Dolmer does not teach canola oil or hydrogenated canola oil.
Krzysik et al. (hereinafter Krzysik) teaches formulations which may be topically applied to the skin to improve skin health ([0001]). Krzysik teaches that the topical ointment may comprise an emollient which are typically substantially water free and which typically softens, soothes, supples, coats, lubricates, and/or moisturizes the skin ([0022]-[0024]) and suitable emollients include canola oil and partially hydrogenated vegetable oils ([0026]).
Accordingly, because Dolmer teaches that the composition may comprise oils and waxes such as vegetables and hydrogenated vegetable oils, it would have been obvious to have simply substituted the vegetable oil and hydrogenated vegetable oil in Dolmer’s composition with canola oil and hydrogenated canola oil, respectively. It would have been obvious to have made this substitution because canola oils were previously known to be useful as emollients in topical skincare compositions and because Krzysik teaches this oil as being interchangeable with other vegetable oils such as avocado oil, borage oil, castor oil, chamomile, coconut oil, corn oil, cottonseed oil, etc. ([0026]). As such, because these vegetable oils were known to be interchangeable components for the purpose of softening, soothing, suppling, coating, lubricating, and/or moisturizing the skin (Krzysik, [0022]-[0024]), a person having ordinary skill in the art would have recognized the potential of canola oil be a type of vegetable oil useful in Dolmer’s composition and would have made this substitution with a reasonable expectation of success. This obviousness is based upon the “Simple Substitution of One Known Element for Another to Obtain Predictable Results” rationale set forth in in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Thus, claim 2 is obvious over Dolmer in view of Sjӧberg and Krzysik.
Conclusion
No claim is allowed.
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.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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