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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 24 March 2025.
CLAIMS UNDER EXAMINATION
Claims 1, 3, 5-8 and 11-12 are pending and have been examined on their merits.
PRIORITY
The Applicant claims priority to Provisional Application 63/211887, filed on 17 June 2021. The Provisional Application does not provide support for the deposited strains now recited in claim 3: “DSM 35551”, “DSM 35552” and “DSM 35553”.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS:
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-8 and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Question 1: Are the claims directed to a process, machine manufacture or composition of matter? Yes, claims 1, 3, 5-8 and 11-12 are directed to a composition of matter.
Question 2A: Are the claims directed to a product of nature, a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?
Prong 1. Yes, claims 1, 3, 5-8 and 11-12 are directed to a nature-based product limitation. The limitation in the claims that sets forth a nature based product are:
Claim 1 recites a composition consisting of 1) a mixture of probiotic bacterial strains, 2) an herbal mix and 3) a nutritionally acceptable carrier, diluent, excipient, adjuvant or nutritionally active ingredient.
The closest naturally occurring counterparts are the individual bacteria and herbs. The specification indicates the strains recited in claim 1 are each naturally occurring ([0077] of PG Pub). As evidenced by the Instant Specification, vasaka, turmeric and holy basil are naturally occurring plants ([0094]). The specification identifies water as a diluent ([0074]). Claim 1 encompasses a capsule. The specification does not define a capsule. A capsule is small container for the claimed ingredients that does not result in significantly more than the recited judicial exceptions. A powder is a mixture of dry particles. A mixture of dried ingredients does not result in significantly more than the recited judicial exceptions.
The nature based product lacks markedly different characteristics (and thus is a product of nature exception) because: When the claimed components are compared to their natural counterparts, they do not have different chemical characteristics. The Instant Specification does not indicate the claimed strains are not found in nature, or manipulated in such a way to produce something markedly different than a strain found in nature. The Instant Specification does not indicate the claimed plants are markedly different than those found in nature.
Prong Two: Do the claims recite additional elements that integrate the judicial exception into a practical application? No. The claims are directed to a product (i.e. a composition) and not a method of administration to a subject.
Question 2B: Do the claims recite any additional elements that amount to significantly more than the judicial exception?
(a) Are there any additional elements recited in the claim beyond the exception identified above? Yes.
(b) Do the additional elements, taken individually and as a combination result in significantly more? No.
Claim 3 recites the tradename of the strains. The Instant Specification does not indicate the claimed strains have been manipulated in such a way as to produce something markedly different than a strain found in nature.
Claim 5 recites a bacteria that is heat-killed. Therefore the claim is directed to how a bacteria is killed. Dead bacteria occur in nature. The limitation directed to how a bacteria is killed does not produce something markedly different.
Regarding claims 6-7, the Instant Specification does not provide evidence indicating the claimed ranges of concentrations change the judicial exceptions to amount to something significantly more or markedly different than the judicial exceptions. Examiner notes water reads on an excipient. Therefore the excipients recited in claims 6-7 encompass a judicial exception.
Claim 8 recites silica as an excipient. It is well known in the art that silica is a naturally occurring mineral. Therefore it is a judicial exception. The Instant Specification does not indicate combining silica with the strains and plants identified as judicial exceptions will produce something markedly different than the judicial exceptions themselves.
Claim 11 recites a vitamin, micronutrient, mineral, prebiotic, fatty acid, amino acid or combination thereof. Each of these components encompasses naturally occurring components (hence, judicial exceptions). The vitamins and minerals recited in claim 12 are naturally occurring (hence, judicial exceptions).
Therefore, claims 1, 3, 5-8 and 11-12 are not eligible subject matter under 35 USC 101.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 14 October 2025 are acknowledged. The arguments state the Declaration filed on 24 March 2025 demonstrates synergistic results when the claimed ingredients are combined. The Applicant argues synergistic results are observed at all ratios and concentrations of ingredients.
EXAMINER’S RESPONSE
The Declaration under 37 CFR 1.132 by Dr. Vivek Lal filed on 24 March 2025 was previously considered in the Office Action mailed on 14 April 2025. As stated in the response, the Declaration is insufficient to overcome the rejection made under 35 USC 101 because: Figure 1 indicates an effect is observed with the combination of Lactobacilli and herbal mix. It is also noted the effect changes due to concentration. None of the claims are commensurate with the ratios and concentrations used in the experiments that produce the effect. The Applicant has not claimed the concentrations that cause the synergistic effect. The Applicant has only provided arguments, without providing evidence, of a synergistic effect at all ratios and concentrations of ingredients.
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 3, 6 and 8 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 3 and 6 have been amended to recite L. plantarum DSM 35551, L. acidophilus DSM 35552 and L. rhamnosus DSM 35553. The specification does not disclose strains with the claimed deposit numbers.
The recited limitations are not supported by the original disclosure, and are considered new matter. An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 14 October 2025 are acknowledged. The Applicant states all the previously claimed strains were typographical errors. The Applicant states the strains that are now claimed are associated with the following registered trademarks: RSB11, RSB12 and RSB13.
EXAMINER’S RESPONSE
Neither the Provisional Application or Non-Provisional Application provide support for the deposit numbers now claimed. A trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. A trademark or trade name does not define or describe the goods associated with the trademark or trade name. Applicant’s assertion that the Provisional Application recites the trademarks, and the trademarks contain the amended deposit numbers is insufficient. See MPEP 2163. The Applicant must provide evidence the trademarks RSB11, RSB12 and RSB13 inherently contain the claimed deposited bacteria. The deposits are new matter.
Claims 3, 6, 8 and 10-12 are rejected 35 U.S.C.§ 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent the strains of Lactobacillus plantarum, Lactobacillus acidophilus and Lactobacillus rhamnosus recited in claim 3 are required to practice the claimed invention. The specification discloses live cultures of “Lactobacillus plantarum RSB11.RTM, Lactobacillus acidophilus RSB12.RTM, and Lactobacillus rhamnosus RSB13.RTM” were deposited pursuant to the requirements of the Budapest Treaty on Nov. 19, 2021 with the American Type Culture Collection Patent Depository and received the deposit numbers PTA-127171 (Lactobacillus plantarum RSB11.RTM), PTA-127172 (Lactobacillus acidophilus RSB12.RTM), and PTA-127173 (Lactobacillus rhamnosus RSB13.RTM), respectively (see page 10 line 30 bridging line 4 page 11).
The claims have been amended to recite L. plantarum DSM 35551, L. acidophilus DSM 35552 and L. rhamnosus DSM 35553. The specification does not disclose these deposits. Budapest treaty Deposit Forms have not been filed for the strains as recited in the claims.
The biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of L. plantarum DSM 35551, L. acidophilus DSM 35552 and L. rhamnosus DSM 35553.
There is no indication the Applicant has complied with CFR 1.808. Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35 USC 122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985) (citing 35 USC 114)); and
(2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
The Instant Specification does not indicate the strains recited in claim 3 has been accepted. The Examiner requests a copy of the Budapest treaty from indicating the material has been accepted by the ATCC.
Claims 3, 6, 8 and 11 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.
Claim 3 has been amended to recite DSM 35551, DSM 35552 and DSM 35553. A Budapest treaty has not been filed for the claimed deposit numbers. The specification does not disclose the claimed deposit numbers. The metes and bounds of the claims are unclear. Appropriate correction is required. All dependent claims are included in this rejection.
Claim 11 recites “the at least one nutritionally active ingredient”. Claim 1 does not recite “at least one” . It is unclear if claim 11 is referring to “a nutritionally active ingredient” as recited in claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lal et al. (previously cited; Inhaled Respiratory Probiotics For Lung Diseases Of Infancy, Childhood and Adulthood WO2018/191073 18 October 2018) in view Doshi et al. (previously cited; Herbal Cough Formulations And Process For The Preparation Thereof. US2006/0257507 2006) as evidenced by Medical News Today (previously cited; What is the difference between prebiotics and probiotics? 29 October 2018) and Merriam Webster (ingredient).
Lal et al. teach a probiotic composition which contains a combination of Lactobacilli species (Abstract). Lal teaches formulation as a capsule, suspension or powder (page 10, lines 7-10). Lal teaches “the bacterial population can consist of L. plantarum, L. acidophilus and L. rhamnosus” (page 2, lines 12-13). This reads on the “consisting of” claim language recited in instant claim 1. The bacterial population “can be suspended in a pharmaceutically acceptable carrier” (see page 2, lines 28-29). Because the composition is administered, it is interpreted to be a nutritionally acceptable carrier.
Lal teaches the composition may contain at least one therapeutic agent that reduces a symptom or effect of bronchopulmonary disease (page 2, lines 22-25). The therapeutic can be an anti-inflammatory agent or an anti-oxidant (page 2, lines 26-27).
Lal also teaches the following:
The disclosed probiotic composition is for the treatment of bronchopulmonary dysplasia, cystic fibrosis lung disease and chronic obstructive pulmonary disease (page 1, lines 9-11). Lal teaches the following (page 8, lines 27-36):
The term "bronchopulmonary disease" as used herein refers to a disease of the
respiratory system, including the lungs and bronchial tree. Pulmonary diseases include, but
are not limited to, cystic fibrosis, Chronic Obstructive Pulmonary Diseases (COPD),
emphysema, asthma, sarcoidosis, chronic bronchitis, bronchopulmonary dysplasia,
pulmonary fibrosis, pneumonia, and adult respiratory distress syndrome. The term
"respiratory diseases", as used herein, means diseases or conditions related to the
respiratory system. Examples include, but not limited to, airway inflammation, allergy(ies),
asthma, impeded respiration, cystic fibrosis (CF), allergic rhinitis (AR), Acute Respiratory
Distress Syndrome (ARDS), pulmonary hypertension, lung inflammation, bronchitis, airway
obstruction, bronchoconstriction, microbial infection, and viral infection, such as SARS
Lal teaches a composition that can be used to treat lung diseases.
Lal teaches a mixture of bacteria that includes Lactobacillus plantarum, Lactobacillus acidophilus and Lactobacillus rhamnosus. Lal teaches a nutritionally acceptable carrier that contains the bacteria. The composition can include at least one therapeutic agent.
The deficiencies of Lal are:
Lal is silent regarding the use of holy basil, turmeric or vasaka in the disclosed composition.
Doshi et al. teach a composition for the treatment of chronic respiratory disorders (Abstract). The disorder may be allergic asthma, allergic rhinitis ([0037]). In Example 1, Doshi teaches a product comprising Tulsi (Ocicum sanctum), Hardira (curcuma longa) and vasaka (Adhatoda vasika) ([0059]). As evidenced by the Instant Specification, “Ocicum sanctum” is holy basil (Example 1). As evidenced by the Instant Specification, “curcuma longum” is turmeric extract (Example 1). Therefore the art teaches a product comprising turmeric, vasaka and holy basil. Doshi teaches extracts are used ([0034] [0040]).
The specification does not define a “nutritionally active ingredient”. As evidenced by Merriam Webster, an ingredient is something that is a component part of any combination or mixture. A product comprising holy basil extract, turmeric extract and vasaka that is added to the composition taught by Lal is broadly interpreted to be a nutritionally active ingredient.
It would have been obvious to combine the teachings of the prior art by using the composition taught by Doshi as an ingredient in Lal’s composition. Lal teaches a composition of the claimed probiotics in a suspension for treating respiratory conditions and Doshi teaches a composition for treating the same conditions. The MPEP teaches it prima facia obvious to combine two compositions, each of which is taught by the prior art to be used for that very same purpose. One would combine the bacteria composition taught by Lal with the composition taught by Doshi to provide an enhanced treatment for respiratory disorders. One would have had a reasonable expectation of success sine Lal teaches the probiotic mixture can be combined with additional therapeutic agents. One would have expected similar results since both references are directed to compositions for treating respiratory disorders. Combining 1) a suspension containing only the claimed probiotics in a pharmaceutically acceptable carrier with 2) a nutritionally active ingredient containing holy basil extract, turmeric extract and vasaka extract would meet the consisting of language recited in the claim.
The rejections under 35 USC 103 above are consistent with case law. Applicants are referred to In re Kerkoven (205 USPQ 1069) in which it was shown to be prima facia obvious to combine two compositions, each of which is taught by the prior art to be used for that very same purpose. Ex Parte Quadranti (25 USPQ2d 1071) also sets forth this precedent, in that the use of materials in combination, each of which is known to function for the intended purpose, is generally held to be prima facia obvious. Ex parte Kucera (165 USPQ 332) clearly states that synergism has no magical status in rendering otherwise obvious subject matter patentable.
Therefore claim 1 is rendered obvious.
While Lal teaches the bacteria composition may contain L. plantarum, L. acidophilus and L. rhamnosus, Lal does not teach the deposits recited in claim 3.
Examiner notes no sequences have been provided for the deposited strains recited in claim 3. The Instant Specification identifies the claimed species as probiotics. The specification does not indicate the recited strains have been genetically modified.
As evidenced by the Instant Specification, the inflammatory cascade is inhibited or prevented by Lactobacillus ([0087]). The Instant Specification discloses “probiotic Lactobacillus spp. reduce the inflammation of lungs in various lung diseases by reduction of neutrophilic inflammation” ([0087]). Lal teaches a combination of Lactobacillus decreases neutrophilic inflammation (MPO) in a lung injury model (Figure 25). Lal teaches the inflammatory cascade shown in Figure 1 is prevented by Lactobacillus (page 14, lines 30-31). Lal teaches probiotic Lactobacillus reduces the inflammation of lungs in various lung diseases by inhibition of neutrophilic inflammation (see page 14, lines 32-33). Therefore the strains taught by Lal have the same mechanism of action and treat the same disorder.
In the absence of evidence to the contrary, the Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus acidophilus taught by the prior art are expected to be the same as those recited in claim 3 or an obvious variant. If, however, the strains disclosed by Lal are not the species deposited then it would have been obvious to use Lal’s species for those claimed as they possesses the same identifying characteristics and are obvious variants. One would expect the same results since, as evidenced by the Instant Species, Lactobacillus have the ability to inhibit or reduce inflammation. Therefore claim 3 is rendered obvious.
Lal teaches in some embodiments, at least one of the Lactobacillus species is heat-killed (page 2, lines 16-17). Therefore claim 5 is included in this rejection .
Lal teaches the strains are present in an amount between 104 to 109 cfu/g of dry composition (page 16, lines 5-6). The art teaches the use of excipients. Suitable pharmaceutical carriers also include excipients such as glucose, lactose, sucrose, glycerol monostearate, sodium chloride, glycerol, propylene, glycol, water, ethanol and the like (page 12, lines 12-15). It would have been obvious to optimize the amount of carrier relative to the bacteria mix taught by Lal. One would do so based on the desired formulation. One would optimize the amount of the recited strains since Lal teaches the probiotic can be present at a concentration of 104 to 109 cfu/g. A probiotic has health benefits. The skilled artisan would optimize the concentration based on the desired effect. See MPEP 2144.05 [R-5]. Therefore claim 6 is rendered obvious.
Doshi teaches the composition contains 25% ocimum sanctum, 15.5% curcuma longa and 15% vasaka. The art teaches the ingredients are adjusted as to deliver 400 mg of the total extracts in 10 ml of an aqueous solution (hence, an excipient) ([0060]). Therefore claim 7 is included in this rejection,
Lal teaches the use of silica as an excipient (page 12, line 8). Therefore claim 8 is rendered obvious.
Lal teaches the lung microbiome may be manipulated to correct dysbiosis and restore "healthy" microbial communities via use of probiotics and prebiotics (see page 34, lines 27-29). As evidenced by Medical News Today, a “prebiotic” is a type of fiber (see first paragraph on page 1). Therefore Lal suggests the use of a prebiotic fiber to correct dysbiosis. Therefore claim 11 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lal in view of Doshi as applied to claim 1 above, and further in view of Park et al. (Dietary vitamin C intake protects against COPD: the Korea national health and nutrition examination survey in 2012. International Journal of COPD 2016:11 2721–2728).
Claim 1 is rejected on the grounds set forth above. The teachings of Lal and Doshi are reiterated.
Lal does not teaches the composition contains vitamin C.
Park teaches the main contributing factors for development of COPD include reduced antioxidant capacity (page 2726, left column, first paragraph). Park teaches intake of vitamin C, an antioxidant, is a risk factor for COPD (page 2724, left column, last paragraph). Park teaches Vitamin C intake is protective against COPD (page 2724, right column, last paragraph; see page 2726, left column, last paragraph).
It would have been obvious to use vitamin C in the composition taught by Lal. Lal teaches a probiotic composition which can be used to treat COPD and Park teaches Vitamin C is an antioxidant that can be used to reduce the risk of COPD. One would use it as a nutritionally active ingredient since Lal teaches adding additional therapeutic agents that treat respiratory disorders. One would have had a reasonable expectation of success since Lal teaches therapeutic agents can be used in the disclosed composition. Therefore claim 12 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 14 October 2025 are acknowledged.
Argument 1: The Applicant argues the Declaration filed on 16 January 2024 provides evidence the “strains are not necessarily interchangeable when it comes to producing a specific, synergistic biological output independent of the host system”. The Applicant argues the Declaration filed on 24 March 2025 provides evidence “the combination of vasaka, holy basil and turmeric perform better than individual herbs, suggesting that the combination provides an unexpected synergy”.
Response to Argument 1:
The Declaration filed on 16 January 2024 was previously considered. The Declaration discloses experiments that require a “resB formulation”. The claims do not require a “resB formulation”. It is unclear what strains are used in the “resB formulation. Therefore the experiments in the Declaration are not commensurate with the claims.
The Declaration filed on 24 March 2025 was previously considered. The Declaration discloses the use of DSM 35338, DSM 35352 and DSM 35339. While claim 3 recites deposit numbers, they are DSM 35551, DSM 35552 and DSM 35553. The experiments in the Declaration are not commensurate with the claims.
Argument 2: The Applicant argues Lal does not teach the claimed herbs, and Doshi does not teach the claimed herbs would act synergistically with each other or with a probiotic composition.
Response to Argument 2: As set forth above, Lal teaches a bacteria mixture that consists of L. plantarum, L. acidophilus and L. rhamnosus. The strains are in a suspension of a nutritionally acceptable carrier. Doshi teaches a composition that reads on a nutritionally active ingredient. Lal and Doshi teach compositions for treating respiratory disorders. The rejections under 35 USC 103 above are consistent with case law. Applicants are referred to In re Kerkoven (205 USPQ 1069) in which it was shown to be prima facia obvious to combine two compositions, each of which is taught by the prior art to be used for that very same purpose. Examiner notes none of the claims require the strains the Applicant argues provide a synergistic effect.
Therefore the arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653