DETAILED ACTION
Applicant’s amendment submitted on 1/17/2025 is acknowledged. Claims 51-52 are newly added. Claim 36 is currently amended. Claim 48 is canceled. Claims 1-35 and 37-41 were previously canceled. Claims 36, 42-47, and 49-52 are pending in the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/17/2025 has been entered.
Priority
The instant application is a U.S. national phase of PCT/EP2012/060948, filed on 6/8/2012, and claims foreign priority to EP11185851.0, filed on 10/19/2011, and EP11169137.4, filed on 6/8/2011, and receipt of certified copies of the foreign priority documents is acknowledged. However, no English translation of the foreign priority documents has been provided to perfect priority, therefore the effective filing date of the instant claims is considered to be the filing date of the international application, 6/8/2012. See 37 CFR 1.55.
Response to Amendment
Applicant’s amendment to the Specification has overcome the objection previously set forth in the Final Rejection mailed on 12/15/2023. Accordingly, the objection is withdrawn.
Claim Objections
Claim 36 is objected to because of the following informalities:
Claim 36 recites “wherein co-aggregates are formed with between Helicobacter pylori and Lactobacillus reuteri DSM 17648” which is ungrammatical.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Indefinite
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 51-52 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 51 recites the limitations “under conditions described in Example 3,” “under conditions described in Example 4,” and “under conditions described in Example 6” in lines 8-9, 11-12, and 14-15, respectively. It is not clear if all conditions listed under Examples 3, 4, and 6 or if any of the conditions listed under Examples 3, 4, and 6 must be met to satisfy the claimed limitations. One of ordinary skill in the art would not be able to determine the metes and bounds of the claim. The specific conditions required in the claims are to be recited in the claim to clearly indicate the structural limitations required in claim 51.
Claim 52 is also rejected for being dependent on a rejected base claim and failing to remedy the issues set forth above.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 36, 42-44, 46-47, and 49-52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boettner (US2007/0148149; Applicant IDS; Of Record) in view of Teixeira (Journal of Applied Bacteriology, 1995; Of Record) as evidenced by Holz et al. (Probiotics & Antimicro. Prot., 2015, Vol. 7, p.91-100; Of Record).
Regarding claims 36, 42-43, 47 and 49-50, Boettner teaches compositions comprising Lactobacillus cells which are capable of aggregating Helicobacter pylori under conditions of the human digestive tract and use of such compositions (see Abstract). Boettner teaches administering its pharmaceutical composition comprising viable Lactobacillus cells to a person for the prophylaxis and/or treatment of diseases caused by infection with Helicobacter pylori (see para [0023] and Claim 14). Boettner teaches the Lactobacillus strains to be selected from DSM 17646, DSM 17647, DSM 17648, DSM 17649, DSM 17650, DSM 17651, DSM 17652 and DSM 17653, and demonstrates their examples with DSM 17648 (see para [0021], Examples 2-4, and Claim 1). Boettner teaches DSM 17646, DSM 17649, DSM 17652 and DSM 17653 are Lactobacillus brevis strains (see para [0021] – reads on claim 42). Even though Boettner discloses DSM 17648 is a Lactobacillus fermentum strain (see para [0021]), in light of the instant amended claim 36, Boettner teaches a Lactobacillus reuteri strain when disclosing DSM 17648 (for evidence - see Abstract of Holz). Boettner teaches the bacteria to be present in lyophilized/freeze-dried form (see paras [0024]-[0027]). Boettner teaches the Lactobacillus strains in its compositions are capable of binding to free Helicobacter pylori to form aggregates in culture conditions of the stomach, reading on wherein co-aggregates are formed between Helicobacter pylori and Lactobacillus reuteri DSM 17648 and claim 47 (see para [0017]). Boettner further teaches lyophilization of Lactobacillus has no effect on its H. pylori aggregation ability (see para [0044]). Boettner further teaches the size of the co-aggregates comprising Lactobacillus and H. pylori to be between 1 µm to 1,000 µm and more (see paras [0020], [0038], and Fig. 1A – reads on wherein the co-aggregates are larger than 50 µm and the limitations of claims 49-50). Boettner teaches these large aggregates can no longer reach and infect epithelial cells in the stomach and therefore prevents gastritis, stomach cancers, and stomach ulcers (see paras [0018] and [0023]). Boettner teaches administering the same Lactobacillus strains as in instant claims to a person to treat Helicobacter pylori infections and teaches its compositions forms aggregates with Helicobacter pylori in culture conditions of the stomach. Therefore, it is expected its methods would also result in the formation of co-aggregates of its compositions with Helicobacter pylori in situ after application in the stomach medium, reading on claim 43.
Boettner teaches the bacteria to be present in lyophilized form (freeze-dried) but does not teach the bacteria to be in spray-dried form.
However, spray drying is an alternative and known technique in the art to prepare bacterial compositions. Teixeira teaches that spray drying is an alternative method to freeze drying and compares the viability of Lactobacillus bulgaricus bacteria when prepared by the two methods (see Abstract and Table 1). Teixeira teaches by comparison of the two methods, spray-drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained (see p.460, left column, 4th paragraph, p.461, left column, 2nd paragraph). Teixeira also teaches spray drying is preferable to freeze drying because it has a lower cost and that spray drying of lactic acid bacteria dates back to 1914 (p.456, left column, 1st paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the instant invention, to modify the compositions of Boettner and prepare the bacteria in the compositions of Boettner using spray-drying instead of freeze drying. One of ordinary skill in the art would have been motivated to do so because the artisan is using a known alternative drying method to prepare the bacteria and it is cheaper compared to freeze drying as taught by Teixeira. Since Boettner teaches the same Lactobacillus strains as instantly claimed and the strains in freeze-dried form are capable to form aggregates with H. Pylori, it would have been reasonable to expect that spray-dried bacteria would also cause aggregates, since Teixeira teaches by comparison of the two methods, spray drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained.
With respect to the limitations “wherein the co-aggregates are larger in size compared to using the same composition comprising non-spray-dried Lactobacillus reuteri DSM 17648” and “wherein the co-aggregates are larger than 50 µm,” the limitations pertaining to the size of the co-aggregates are intended outcomes of the recited method. Boettner teaches administering its pharmaceutical composition comprising viable Lactobacillus cells to a person for the prophylaxis and/or treatment of diseases caused by infection with Helicobacter pylori (see para [0023] and claim 14) and teaches the same Lactobacillus strain, DSM 17648, (see para [0021]) as instantly claimed). Boettner teaches the Lactobacillus strains in its compositions are capable of binding to free Helicobacter pylori to form aggregates in culture conditions of the stomach (see para [0017]). Teixeira teaches that lactic acid bacteria are commonly spray-dried and is an alternative technique to freeze-drying. The combined teachings of Boettner in view of Teixeira teach the same method steps of preparing spray-dried bacterial compositions (same strain - DSM 17648) and administering it to a subject to treat H. pylori as instantly claimed. Therefore, it is expected that the method of Boettner in view of Teixeira would also result in the co-aggregates being the same size as instantly recited.
Regarding claim 44, Boettner teaches the compositions can be prepared as pharmaceutical compositions comprising suitable active substances (see para [0025]).
Regarding claim 46, the limitation that the “Lactobacillus cells are essentially present in monomer and/or dimer form” is an intended outcome of the spray-drying method. Since Boettner teaches the same Lactobacillus strains as instantly claimed and Teixeira teaches that lactic acid bacteria are commonly spray-dried and is an alternative technique to freeze-drying, the combined teachings of Boettner in view of Teixeira teach the same method steps of preparing the bacterial compositions (same strains) as instantly claimed. Therefore, it is expected that the composition as prepared by the teachings of Boettner in view of Teixeira would also result in a composition wherein the “Lactobacillus cells are essentially present in monomer and/or dimer form”.
Regarding claims 51-52, Boettner teaches compositions comprising Lactobacillus cells which are capable of aggregating Helicobacter pylori under conditions of the human digestive tract and use of such compositions (see Abstract). Boettner teaches administering its pharmaceutical composition comprising viable Lactobacillus cells to a person for the prophylaxis and/or treatment of diseases caused by infection with Helicobacter pylori (see para [0023] and Claim 14). Boettner teaches the Lactobacillus strains to be selected from DSM 17646, DSM 17647, DSM 17648, DSM 17649, DSM 17650, DSM 17651, DSM 17652 and DSM 17653, and demonstrates their examples with DSM 17648 (see para [0021], Examples 2-4, and Claim 1). Boettner teaches DSM 17646, DSM 17649, DSM 17652 and DSM 17653 are Lactobacillus brevis strains (see para [0021]). Even though Boettner discloses DSM 17648 is a Lactobacillus fermentum strain (see para [0021]), in light of the instant amended claim 36, Boettner apparently teaches a Lactobacillus reuteri strain when disclosing DSM 17648 (for evidence - see Abstract of Holz). Boettner teaches the bacteria to be present in lyophilized/freeze-dried form (see paras [0024]-[0027]). Boettner teaches the Lactobacillus strains in its compositions are capable of binding to free Helicobacter pylori to form aggregates in culture conditions of the stomach, reading on wherein co-aggregates are formed between Helicobacter pylori and Lactobacillus reuteri DSM 17648 (see para [0017]). Boettner further teaches lyophilization of Lactobacillus has no effect on its H. pylori aggregation ability (see para [0044]). Boettner further teaches the size of the co-aggregates comprising Lactobacillus and H. pylori to be between 1 µm to 1,000 µm and more (see paras [0020], [0038], and Fig. 1A – reads on wherein the co-aggregates are larger than 50 µm as recited in claim 51). Boettner teaches these large aggregates can no longer reach and infect epithelial cells in the stomach and therefore prevents gastritis, stomach cancers, and stomach ulcers (see paras [0018] and [0023]). Boettner teaches administering the same Lactobacillus strains as in instant claims to a person to treat Helicobacter pylori infections and teaches its compositions forms aggregates with Helicobacter pylori in culture conditions of the stomach, reading on under conditions described in Examples 3, 4, and 6.
Boettner teaches the bacteria to be present in lyophilized form (freeze-dried) but does not teach the bacteria to be in spray-dried form.
However, spray drying is an alternative and known technique in the art to prepare bacterial compositions. Teixeira teaches that spray drying is an alternative method to freeze drying and compares the viability of Lactobacillus bulgaricus bacteria when prepared by the two methods (see Abstract and Table 1). Teixeira teaches by comparison of the two methods, spray-drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained (see p.460, left column, 4th paragraph, p.461, left column, 2nd paragraph). Teixeira also teaches spray drying is preferable to freeze drying because it has a lower cost and that spray drying of lactic acid bacteria dates back to 1914 (p.456, left column, 1st paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the instant invention, to modify the compositions of Boettner and prepare the bacteria in the compositions of Boettner using spray-drying instead of freeze drying. One of ordinary skill in the art would have been motivated to do so because the artisan is using a known alternative drying method to prepare the bacteria and it is cheaper compared to freeze drying as taught by Teixeira. Since Boettner teaches the same Lactobacillus strains as instantly claimed and the strains in freeze-dried form are capable to form aggregates with H. Pylori, it would have been reasonable to expect that spray-dried bacteria would also cause aggregates, since Teixeira teaches by comparison of the two methods, spray drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained.
With respect to the limitations “wherein the co-aggregates are larger in size compared to using the same composition comprising non-spray-dried Lactobacillus reuteri DSM 17648,” “wherein the co-aggregates have increased stability compared to using the same composition comprising non-spray-dried Lactobacillus reuteri DSM 17648,” and “wherein the degree of co-aggregation is more than twice that compared to using a composition comprising non-spray-dried Lactobacillus reuteri DSM 17648,” these limitations are intended outcomes of the recited method. Boettner teaches administering its pharmaceutical composition comprising viable Lactobacillus cells to a person for the prophylaxis and/or treatment of diseases caused by infection with Helicobacter pylori (see para [0023] and claim 14) and teaches the same Lactobacillus strain, DSM 17648, (see para [0021]) as instantly claimed). Boettner teaches the Lactobacillus strains in its compositions are capable of binding to free Helicobacter pylori to form aggregates in culture conditions of the stomach (see para [0017]). Teixeira teaches that lactic acid bacteria are commonly spray-dried and is an alternative technique to freeze-drying. The combined teachings of Boettner in view of Teixeira teach the same method steps of preparing spray-dried bacterial compositions (same strain - DSM 17648) and administering it to a subject to treat H. pylori as instantly claimed. Therefore, it is expected that the method of Boettner in view of Teixeira would also result in the co-aggregates having the same properties as recited in claim 51.
Therefore, the combination of Boettner and Teixeira renders claims 36, 42-44, 46-47, and 49-52 prima facie obvious.
Claim 45 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boettner (US2007/0148149; Applicant IDS; Of Record) in view of Teixeira (Journal of Applied Bacteriology, 1995; Of Record) as evidenced by Holz et al. (Probiotics & Antimicro. Prot., 2015, Vol. 7, p.91-100; Of Record), as applied to claims 36, 42-44, 46-47, and 49-52 above, and further in view of Lesbros-Pantoflickoba (J. Nutrit., 2007, Vol. 137, p.812S-818S; hereinafter LP; Of Record).
Boettner in view of Teixeira teach the invention of claims 36 and 44 as discussed in the rejection above.
Regarding claim 45, neither Boettner nor Teixeira teach said suitable active ingredients are antibiotics.
LP teaches combination treatments with probiotics (Lactobacillus) and antibiotics reduces side effects and improves Helicobacter pylori eradication (see Abstract, p.814S, right column, last two paragraphs, p.815S, left column, last two paragraphs, full right column, and Table 4). LP further teaches probiotic treatment with Lactobacillus decreases H. pylori bacterial loads and reduces frequency of diarrhea. Furthermore, LP teaches growth of Helicobacter pylori is inhibited by Lactobacillus reuteri by inhibiting the binding of H. pylori to glycolipid receptors (see p.813S, right column, 1st paragraph, and Table 1).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the method of prophylaxis and/or treatment of diseases caused by infection with Helicobacter pylori by administering the Lactobacillus composition of Boettner in view Teixeira to include antibiotics as taught by LP, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because LP teaches the combination of Lactobacillus and antibiotics is effective at improving H. pylori eradication and reducing side effects, which would yield predictable results. Furthermore, it 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. See MPEP § 2144.06.
Thus, the combination of Boettner, Teixeira, and LP renders claim 45 prima facie obvious.
Response to Arguments
Applicant's arguments filed 1/17/2025 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.5, 2nd-last paragraphs, Applicant argues that Boettner does not teach or suggest using spray-dried Lactobacillus reuteri cells, specifically Lactobacillus reuteri DSM 17648 cells of the amended claims, to form co-aggregates with H. pylori. Applicant argues that Teixeira does not teach or suggest using Lactobacillus reuteri cells, specifically Lactobacillus reuteri DSM 17648 cells of the amended claims, nor does Teixeira teach or suggest spray-dried Lactobacillus reuteri to form co-aggregates with H. pylori. Applicant further argues that nowhere does the prior art teach or suggest using the claimed spray-dried Lactobacillus reuteri DSM 17648 cells for treatment of an infection by H. pylori, and that the Office has failed to show that the art as a whole would teach or suggest using the selected strain of Applicant’s claimed invention with the expectation of the Applicant’s surprising results. This is not found persuasive. Boettner teaches the Lactobacillus strains to be selected from DSM 17646, DSM 17647, DSM 17648, DSM 17649, DSM 17650, DSM 17651, DSM 17652 and DSM 17653, and demonstrates their examples with DSM 17648 (see para [0021], Examples 2-4, and Claim 1). Boettner teaches DSM 17646, DSM 17649, DSM 17652 and DSM 17653 are Lactobacillus brevis strains (see para [0021]). Even though Boettner discloses DSM 17648 is a Lactobacillus fermentum strain (see para [0021]), in light of the instant amended claim 36, Boettner apparently teaches a Lactobacillus reuteri strain when disclosing DSM 17648 (for evidence - see Abstract of Holz). Boettner teaches the bacteria to be present in lyophilized/freeze-dried form (see paras [0024]-[0027]). Boettner teaches the Lactobacillus strains in its compositions are capable of binding to free Helicobacter pylori to form aggregates in culture conditions of the stomach, reading on wherein co-aggregates are formed between Helicobacter pylori and Lactobacillus reuteri DSM 17648 (see para [0017]). Boettner further teaches lyophilization of Lactobacillus has no effect on its H. pylori aggregation ability (see para [0044]). While Boettner does not teach the Lactobacillus DSM 17648 is in spray-dried form, Teixeira teaches that spray drying is an alternative method to freeze drying and compares the viability of Lactobacillus bulgaricus bacteria when prepared by the two methods (see Abstract and Table 1). Teixeira teaches by comparison of the two methods, spray-drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained (see p.460, left column, 4th paragraph, p.461, left column, 2nd paragraph). Teixeira also teaches spray drying is preferable to freeze drying because it has a lower cost and that spray drying of lactic acid bacteria dates back to 1914 (p.456, left column, 1st paragraph). Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the instant invention, to modify the compositions of Boettner and prepare the bacteria in the compositions of Boettner using spray-drying instead of freeze drying. One of ordinary skill in the art would have been motivated to do so because the artisan is using a known alternative drying method to prepare the bacteria and it is cheaper compared to freeze drying as taught by Teixeira. Since Boettner teaches the same Lactobacillus strains as instantly claimed and the strains in freeze-dried form are capable to form aggregates with H. Pylori, it would have been reasonable to expect that spray-dried bacteria would also cause aggregates, since Teixeira teaches by comparison of the two methods, spray drying and freeze drying (lyophilized), in terms of survival, acid production and extent of the lag phase, no significant differences were obtained. Thus, one of ordinary skill in the art would have been motivated to spray-dry the Lactobacillus strains of Boettner, including Lactobacillus DSM 17648, in order to provide a cheaper method of obtaining dried cells with no significant differences in the dried cells. Considering Boettner teaches the lyophilization process has no effect on the ability of Lactobacillus to form aggregates with H. pylori, an ordinarily skilled artisan would have a reasonable expectation of success modifying the Lactobacillus DSM 17468 of Boettner to be spray-dried rather than lyophilized. Therefore, the claimed invention is prima facie obvious over Boettner in view of Teixeira. It is also noted the instant claims are drawn to administration of a composition comprising dried Lactobacillus, not a method of preparing a composition comprising dried Lactobacillus.
In Applicant’s Remarks, see p.6, 2nd-last paragraphs, Applicant argues that Teixeira teaches that spray drying in general is not a commercial means of preparing lactic acid bacteria because of low survival rates. Applicant further argues that the skilled artisan would have known from the prior art available that survival of bacterial strains to spray drying is unpredictable and dependent on strain selection. Applicant further argues that comparing the survival between spray-dried and freeze-dried Lactobacillus bulgaricus strains described in Teixeira is immaterial to the Lactobacillus reuteri strains in the pending claims in view of survivability of spray-dried Lactobacillus being unpredictable. This is not found persuasive. While Teixeira relates to L. bulgaricus, Teixeira is only relied upon to teach the technique of spray-drying. Boettner is modified by Teixeira to teach spray-dried L. reuteri cells, taught as Lactobacillus DSM 17648, for use in treating infection by H. pylori, as claimed in the present invention. It is the combination of Boettner in view of Teixeira that teach a spray-dried L. reuteri DSM 17648. Boettner is modified in view of Teixeira to teach a spray-dried L. reuteri rather than a freeze-dried L. reuteri as originally taught by Boettner. Teixeira does not state that spray drying cannot be a commercial means of preparing LAB, only that it has not yet been developed. Teixeira states low survivability is mainly the reason behind spray drying not being developed commercially, but not the only reason. Teixeira finds no significant difference in the survival of freeze-dried vs. spray-dried cells. Additionally, the process of spray-drying does not have to be commercial in order to satisfy the claimed invention. See MPEP 2145(VII). While spray-drying may be inconsistent across all bacteria and depends on strain selection, Teixeira provides motivation for an ordinarily skilled artisan to modify the teaching of Boettner in view of Teixeira’s teaching that there are no significant differences between spray-drying and freeze-drying. The assertion that Teixeira’s teachings are immaterial to the present invention is not persuasive because Teixeira compares freeze-drying and spray-drying in a lactic acid bacterium which L. reuteri is and the nature of the teaching is highly relevant.
In Applicant’s Remarks, see p.7, 2nd paragraph-p.8, 1st paragraph, Applicant argues that the Office has provided no teaching in the prior art of a nexus between survival and aggregation, nor any teaching in the prior art the spray-dried bacteria (living or dead) are capable of aggregation with Helicobacter pylori. Applicant further argues that the prior art teaches heat treatment of spray-drying causes additional damage and stress to bacteria that doesn’t occur during freeze-drying. This is not found persuasive. The arguments regarding a nexus between survival and aggregation have been discussed in the responses above. With regards to the prior art teaching heat treatment of spray-drying causing additional damage and stress to bacteria that is absent in freeze-drying, the prior art cited does not teach away from spray-drying. In fact, the prior art is general and states spray-drying can be detrimental and has the same stresses mentioned during freeze-drying. Moreover, the prior art cited does not with certainty teach that spray-drying damages cells and mentions the potential for damage to cells. Furthermore, none of the citations from the prior art cited are with regards to Lactobacillus bacteria and thus Applicant makes assertions taken out of context from the art.
In Applicant’s Remarks, see p.8, 2nd paragraph-p.10, 1st paragraph, Applicant argues that they surprisingly discovered that spray-dried Lactobacillus reuteri DSM 17648 co-aggregates with Helicobacter pylori and that the co-aggregates are larger in size, more stable, and co-aggregate at a larger degree. Applicant argues that Boettner did not demonstrate an increase in co-aggregate size when comparing fresh-culture to lyophilized Lactobacillus in Example 4 of Boettner. Applicant further argues that instant Example 3 surprisingly demonstrates improved stability of co-aggregates using spray-dried L. reuteri DSM 17648, and instant Example 5 demonstrates a surprising degree of co-aggregation using spray-dried L. reuteri DSM 17648. Applicant concludes that spray-dried L. reuteri DSM 17648 have improved aggregation properties over the prior art the were unexpected. This is not found persuasive. The examples of Boettner demonstrate aggregates having sizes from 1 μm to 50 μm and even to 1000 μm and more, and thus the size of aggregates were realized in the prior art (see Example 2, paragraphs [0038], and Fig. 1A). Moreover, Boettner demonstrates that lyophilization had no effect on the ability of Lactobacillus to aggregate H. pylori (see Example 4). Thus, the increased size of the aggregates is not an unexpected result as evidenced by Boettner. As stated above, the instant claims are drawn to a method of administering a dried Lactobacillus composition, not a method for drying Lactobacillus. Furthermore, it would have been obvious to spray-dry the Lactobacillus cells of Boettner rather than lyophilize the cells as discussed above and one of ordinary skill in the art would not have expected surprising results in the ability of aggregation. Applicant did not demonstrate that the properties of aggregation of H. pylori between spray-dried and lyophilized Lactobacillus is surprising, and only showed the differences between fresh culture and spray-dried Lactobacillus. As discussed in the responses above, spray-dried Lactobacillus DSM 17648 for treating H. pylori would have been obvious to one of ordinary skill in the art over Boettner in view of Teixeira, and the results of aggregation would have been expected based on the disclosure of Boettner.
Conclusion
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/J.P.S./Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657