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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 10, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I (i.e., drawn to a method for reducing the risk of vancomycin-resistant Enterococci infection or VRE colonization in a subject, and/or reducing the severity of VRE infection in the subject, and/or reducing the amount of VRE colonizing the subject) in the reply filed on April 4, 2024 is acknowledged.
Status of Claims
Claims 1, 3-5, 8, 11-20, and 38-44 are currently pending and under consideration.
Priority
The present application is a continuation of US application no. 16/870,634 (now Patent 11197897), filed on 05/08/2020, which is a divisional application of US application no. 15/986,369 (now Patent no. 10646520), filed on 05/22/2018, which is continuation of PCT/US2016/063643 filed on 11/23/2016. Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 62/301,873, filed on 03/01/206 and Provisional application No. 62/260,164, filed on 11/25/2015. The present application and all claims are being examined with an effective filing date of November 25, 2015. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejections
In view of Applicant’s remarks filed on 03/10/2026 on pg. 6-8, the rejection of claim 38 under 35 USC § 103 over Henn et al. and Clavel et al. is hereby withdrawn.
Claim Objections
Claim 38 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Maintained Rejections
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.
Claims 1, 3-5, 8, 11-20, 39-44 are rejected under 35 U.S.C. 103 as being unpatentable over Henn et al. (WO2015077794 A1, cited in the IDS).
Regarding claim 1, Henn et al. teaches methods comprising administering to a human subject in need thereof an effective amount of a bacterial composition comprising at least a first type of isolated bacterium, a second type of isolated bacterium, and optionally a third type of isolated bacterium, wherein the first type, second type, and optional third type are independently capable of forming a spore, and wherein at least one of the first type, second type, and optional third type are not identical, such that the composition exerts an inhibitory effect on a pathogenic bacterium present in the gastrointestinal tract of the human subject, whereby the number of pathogenic bacteria present in the gastrointestinal tract is not detectably increased or is detectably decreased over a period of time (pg. 14, para. 024). Henn et al. further teaches that, in one embodiment, the composition consists of between 2 and 20 types of isolated bacteria independently capable of spore formation, wherein the first, second, and third types of isolated bacteria are selected from Table 1. Henn et al. further teaches that the pathogenic bacterium may be vancomycin-resistant Enterococci (VRE) (pgs. 7-9, para. 015). Included in Table 1 are Blautia producta and Clostridium bolteae, and Henn identifies both as spore-forming bacteria.
Henn et al. also teaches that “in some aspects, the invention relates to a composition comprising a network ecology selected from Table 10,” and that, “in some embodiments, the composition the composition is effective for treating at least one sign or symptom of a dysbiosis, for example, the is effective for reducing at least one sign or symptom of infection or dysbiosis associated with C. difficile, Klebsiella pneumonii, Morganella morganii, or vancomycin-resistant Enterococci (VRE)” (pg. 22, para 030). Thus, Henn expressly contemplates the Table 10 network ecologies as compositions of the invention and teaches their use in embodiments directed to VRE-associated infection or dysbiosis. With respect to the limitation that the composition does not comprise (i) Clostridiales VE202-05 and (ii) Clostridium hylemonae and/or Lachnospiraceae bacterium 5_1_57FAA, Henn teaches an exemplary Table 10 network ecology, N1965, that comprises C. bolteae and B. producta and excludes Clostridiales VE202-05 and Clostridium hylemonae, thereby meeting the claimed composition limitations (Table 10, pg. 232).
With respect to the recitation of “reducing the amount of a biomarker of vancomycin-resistant Enterococci (VRE) infection in a subject,” Henn teaches that its bacterial compositions inhibit pathogenic bacteria, including VRE, such that the number of pathogenic bacteria present in the gastrointestinal tract is not detectably increased or is “detectably decreased over time”. Henn further teaches that compositions comprising network ecologies selected from Table 10 may, in some embodiments, be effective for reducing at least one sign or symptom of infection or dysbiosis associated with VRE. In view of these disclosures, a person of ordinary skill in the art would have understood that reducing VRE burden or VRE colonization would reasonably correspond to a reduction in at least one detectable indicator associated with VRE infection, which falls within the broad scope of the claimed “biomarker.”
Henn also teaches analyzing a portion of a subject’s microbiome using 16S sequencing to identify biomarkers, and that such biomarker data may be used to select compositions for administration to inhibit pathogenic bacteria, including VRE. Accordingly, a person of ordinary skill in the art would have had a reasonable expectation of success in using the disclosed Table 10 composition, including N1965, to reduce VRE-associated infection or dysbiosis and thereby reduce VRE-associated biomarker levels.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, Henn’s teachings that an effective amount of a bacterial composition comprising at least two spore-forming bacteria, including C. bolteae and B. producta, is capable of inhibiting pathogenic bacteria including VRE, together with Henn’s express disclosure that Table 10 network ecology N1965 comprises C. bolteae and B. producta while excluding Clostridiales VE202-05 and Clostridium hylemonae, would have motivated a person of ordinary skill in the art to administer the N1965 composition to a subject in need of reducing VRE infection or colonization. Because Henn teaches that such compositions may reduce at least one sign or symptom of infection or dysbiosis associated with VRE, a person of ordinary skill in the art would have had a reasonable expectation that administering the N1965 composition would reduce VRE burden and thereby reduce VRE-associated biomarkers in the subject. Therefore, claim 1 would have been prima facie obvious over Henn et al. before the effective filing date of the claimed invention.
Regarding claims 3-4, as described above, Henn et al. teaches compositions comprising an effective amount of a bacterial composition comprising at least a first type of isolated bacterium capable of forming a spore, a second type of isolated bacterium capable of forming a spore, wherein the first and second types are not identical and are capable of inhibiting the growth and/or colonization of at least one type of pathogenic bacteria. Henn et al. further teaches said composition comprising a third bacterium or more and discloses several ternary composition capable of inhibiting VRE. Of the bacteria capable of forming of spore that can be selected from Table 1 as the third type of isolated bacterium in said composition is Coprococcus catus (pg. 128), which is part of the Lachnospiraceae family, which is part of the Bacillota phylum, also known as the Firmicutes phylum. Additionally, N1965 comprises a member of the Lachnospiraceae family (e.g., Lachnospiraceae bacterium 5_1_57FAA)
Regarding claims 5 and 8, as described above, Henn et al. teaches compositions comprising between 2 and 20 types of isolated bacteria, independently capable of spore formation, wherein the first, second, and third types of isolated bacteria are selected from Table 1, wherein various combination are effective in inhibiting pathogenic bacteria, including VRE. A person of ordinary skill in the art would have been motivated to include additional spore-forming species disclosed in Table 1 to further explore or optimize VRE inhibition, with a reasonable expectation of success. Of the bacteria capable of forming of spore that can be selected from Table 1 is Clostridium sordellii and Clostridium innocuum (pg. 125). Therefore, the subject matter matter of claims 5 and 8 would have been prima facie obvious over Henn et al., in view of the disclosure of “N1965”.
Regarding claim 11, Henn et al. teach isolated bacterial compositions as single dose units comprising a range of colony forming units of viable bacteria (pg. 6, para 011).
Regarding claim 12, as described above, Henn et al. teaches bacterial compositions comprising first and second types of isolated bacteria capable of forming spores (pg. 7, para 015).
Regarding claim 13, Henn et al. teach the bacterial compositions described above for oral, rectal or the combination of oral and rectal administration (pg. 7, para 013).
Regarding claim 14, Henn et al. teaches an embodiment of the composition described above wherein the composition comprises a non-spore forming isolated bacterium as the third bacterium of the composition, selected from Table 1 (pg. 8-9, para 015). Therefore, the composition of Henn et al. described above may further comprise Lactobacillus acidophilus disclosed in Table 1 (pg. 146), which is well-known and widely used as a probiotic bacteria.
Regarding claim 15, Henn et al. teach the bacterial compositions described above as solid dosage forms for oral administration in the forms of capsules, tablets, powders and liquid (pg. 60, para 0180).
Regarding claim 16, Henn et al. teach the simultaneous administration of the composition(s) described above with an antibiotic (pg. 15, para 0024).
Regarding claim 17, Henn et al. teach bacterial compositions for treating diarrhea, reducing the diarrheal effect of a pathogen, wherein the pathogen is…VRE (pg. 21-22, para 029).
Regarding claim 18, as indicated above, Henn et al. teach the bacterial compositions described above, comprising of a combination of the first, second and third types of bacteria, as capable of inhibiting proliferation of the pathogenic bacteria…wherein the pathogenic bacterium is selected from the group consisting of…VRE (pg. 8-9, para 015).
Regarding claims 19-20, Henn et al. teach that “particular bacterial compositions may be selected for individual subjects or for subjects with particular profiles. For example, 16S sequencing may be performed for a given subject to identify the bacteria present in his or her microbiota…or it may be used to detect the presence or absence of specific candidate bacteria that are biomarkers for health or a particular disease state, such as markers of multi-drug resistant organisms...Based on the biomarker data, a particular composition may be selected for administration to a subject to supplement or complement a subject’s microbiota in order to restore health or treat or prevent disease” (pg. 68, para 0207).
Regarding claim 39, Henn et al. teaches an embodiment of the composition described above wherein the composition comprises a non-spore forming isolated bacterium as the third bacterium of the composition, selected from Table 1 (pg. 8-9, para 015). Therefore, the composition of Henn et al. described above may further comprise Parabacteroides distasonis in Table 1 (pg. 124).
Regarding claim 40, as discussed above, Henn et al. teaches compositions that inhibit pathogenic bacteria, including VRE, such that the number of pathogenic bacteria present in the gastrointestinal tract is not detectably increased or is detectably decreased over time. Henn et al. further teaches that Table 10 network ecology compositions are, in some embodiments, effective for reducing at least one sign or symptom of infection or dysbiosis associated with VRE. It would have been obvious to a person of ordinary skill in the art that reducing VRE infection, colonization, or bacterial burden would reduce VRE-specific biomarkers relative to an untreated subject with VRE infection or relative to the same subject prior to treatment. Therefore, administering the composition taught by Henn et al. to a subject in need thereof would have been reasonably expected to reduce the amount of a VRE biomarker to an undetectable amount, or to an amount less than the amount of the biomarker in an untreated subject or in the subject prior to treatment.
Regarding claim 41, Henn et al. discloses methods for identifying bacterial compositions that inhibit the growth of VRE using a VRE selective assay (pg. 82, Example 9). Henn et al. teaches that compositions comprising spore-forming bacteria, including B. producta and C. bolteae, reduce VRE growth in the assay, and that the compositions may be selected for administration to a subject in need thereof. A person of ordinary skill in the art would have understood that inhibition of VRE growth in vitro or in a subject corresponds to reduction in VRE burden, which would be reflected in a reduction in VRE-specific biomarkers. Therefore, a reduction of at least 10% in VRE biomarker levels, relative to an untreated subject or pre-treatment sample, would have been reasonably expected by a person of ordinary skill in the art when using compositions taught by Henn et al.
Regarding claims 42-43, as discussed above, Henn et al. discloses a method of inhibiting the growth of VRE/reducing VRE in a subject infected with VRE, comprising administering to said subject a bacterial composition according to the embodiments detailed above. Also taught by Henn et al., said subject is screened for biomarkers indicating disease state prior to treatment and it would be obvious to a person of ordinary skill in the art to also measure those biomarker levels after treatment, to assess VRE inhibition/reduction. With respect to detecting biomarkers from feces, Henn et al. discloses an exemplary method of treating a subject with recurrent C. difficile infection with a bacterial composition. In the example, stool (i.e., feces) is collected from the subject before and after treatment on day 1, day 3, week 1, and month 1 post treatment, showing reductions in C. difficile by at least 50% to undetectable levels, measured by qPCR. Henn et al. further teaches that “ELISA for toxin protein or traditional microbiological identification techniques may also be used” (pg. 100-101, Example 22). It is noted that a “toxin protein” correlates to a biomarker. It would be obvious for a person of ordinary skill in the art to apply these same techniques (i.e., biomarker detection using a stool sample) to a method of treating a subject with VRE infection, and expect predictable results (“Simple substitution of one known element for another to obtain predictable results, MPEP 2143 I.B.). With respect to culturing a stool, intestinal, sputum, blood urine or would sample for biomarker detection, Henn et al. discloses an assay for screening VRE inhibition by culturing VRE (pg. 81, Example 9). Inhibition is measured according to colony count, however, Henn et al. teaches biomarker detection, as described above. Additionally, Henn et al. discloses an exemplary method of detecting C. difficile from stool, wherein “ stool are gathered from mouse cages (5 mice per cage) each day, and the shedding of C. difficile spores is detected in the stool using a selective plating assay as described for the in vitro assay above, or via qPCR for the toxin gene” (pg. 52-53, para 0155). It is noted that the “toxin gene” correlates to a biomarker and pursuant to MPEP 2143 I.B., it would be obvious for a person of ordinary skill in the art to apply these same techniques (i.e., biomarker detection using a cultured stool sample) to a method of treating a subject with VRE infection, and expect predictable results.
Regarding claim 44, Henn et al. discloses methods comprising administering to a human subject in need thereof an effective amount of a bacterial composition comprising between 2 and 20 types of isolated bacteria, independently capable of spore formation, wherein the first, second, and third types of isolated bacteria are selected from Table 1, and wherein said composition exerts an inhibitory effect on a pathogenic bacterium present in the gastrointestinal tract of the human subject, such that the number of pathogenic bacteria present in the gastrointestinal tract is not detectably increased or is detectably decreased over a period of time (pg. 14, para. 024). Henn et al. teaches the pathogenic bacterium is selected from the group consisting of, inter alia, vancomycin-resistant Enterococci (VRE) (pg. 7-9, para. 015), and included in the list of bacteria in Table 1 are spore-formers Blautia producta (pg. 121) and Clostridium bolteae (pg. 129). With respect to the limitation “wherein the composition does not comprise: (i) Clostridiales VE202-05 and (ii) Clostridium hylemonae and/or Lachnospiraceae bacterium 5_1_57FAA,” as discussed above, Henn et al. discloses exemplary composition “N1965,” comprising B. producta and C. bolteae, while excluding Clostridiales VE202-05 and Clostridium hylemonae, satisfying the limitations of the claimed bacterial composition (Table 10, pg. 232). Regarding percent inhibition, a person of ordinary skill in the art would have understood that inhibition of VRE growth, colonization, or bacterial burden corresponds to reduction in VRE colony forming units. Therefore, a reduction of at least 10% in VRE CFU relative to a pre-treatment sample would have been reasonably expected when using the compositions taught by Henn et al.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Henn et al., that an effective amount of a composition comprising at least 2 spore formers (from Table 1) such as C. bolteae and B. producta is capable of reducing colonization of a pathogenic bacterium, such as VRE, and that the composition disclosed in N1965 can be effective against VRE infection, would have motivated said practitioner to administer to a subject in need of treatment, a composition comprising C. bolteae and B. producta (excluding C. hylemonae and Clostridiales VE202-05). Given that Henn et al. teaches the that VRE is one of the infections that N1965 is effective against, there is a reasonable expectation of success that an effective amount of a composition comprising C. bolteae and B. producta, but not comprising (i) Clostridiales VE202-05 and (ii) Clostridium hylemonae and/or Lachnospiraceae bacterium 5_1_57FAA, would effectively inhibit the growth/colonization of VRE, resulting in at least 10% reduction in VRE CFU in said subject. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments for Prior Art Rejections
In the response filed 03/10/2026, Applicant argues that the rejection fails to establish that Henn et al. renders claim 1 obvious because Henn et al. allegedly does not provide a reasonable expectation that the claimed composition comprising Clostridium bolteae and Blautia producta would reduce the amount of a biomarker of VRE infection or reduce VRE colonization in a subject. Applicant further argues that Henn et al. does not establish that spore-forming bacteria are interchangeable for pathogen inhibition, because Henn et al. discloses certain spore-forming bacterial combinations that did not inhibit VRE or C. difficile. Applicant also argues that Table 10, including network ecology N1965, was tested in connection with C. difficile, not VRE, and that post-filing “Caballero” data allegedly demonstrate the unexpected and unpredictable role of C. bolteae and B. producta together in reducing VRE colonization. Applicant’s arguments have been fully considered but are not persuasive.
First, applicant’s arguments improperly require Henn et al. to provide a working example showing that N1965 itself reduced VRE colonization or reduced a VRE-associated biomarker. Such a showing is not required to establish obviousness. The proper inquiry is whether the prior art as a whole would have provided a reason to administer the claimed composition for the claimed purpose with a reasonable expectation of success, not whether the prior art actually demonstrated the identical method in a working example. Obviousness requires a reasonable expectation of success, not absolute predictability. Pursuant to MPEP 2143.02, “conclusive proof of efficacy is not required to show a reasonable expectation of success” and “obviousness does not require absolute predictability…”.
Here, Henn et al. expressly discloses network ecology N1965 as a Table 10 composition comprising Blautia producta and Clostridium bolteae, while excluding Clostridiales VE202-05 and Clostridium hylemonae. Henn et al. further teaches that the invention relates to compositions comprising network ecologies selected from Table 10 and that, in some embodiments, such compositions are effective for reducing at least one sign or symptom of infection or dysbiosis associated with vancomycin-resistant enterococci (VRE). Thus, Henn et al. provides a direct reason to consider Table 10 network ecology compositions, including N1965, for treatment of VRE-associated infection or dysbiosis.
Second, applicant’s reliance on examples in Henn et al. where certain bacterial combinations did not inhibit VRE or C. difficile does not overcome the rejection. The Office is not relying on a position that every possible combination of spore-forming bacteria would necessarily inhibit every pathogen, nor on unrestricted interchangeability of all spore-formers. Rather, the rejection is based on Henn’s disclosure of the claimed N1965 composition, Henn’s teaching that Table 10 network ecology compositions are compositions of the invention useful in treating infection or dysbiosis, including VRE-associated infection or dysbiosis, and Henn’s express teaching that compositions comprising Table 10 network ecologies may be effective for reducing signs or symptoms of infection or dysbiosis associated with VRE. A reasonable expectation of success does not require certainty or universal efficacy across all disclosed bacterial combinations.
Third, applicant’s argument that Table 10 was tested against C. difficile does not defeat the rejection. The Office acknowledges that Table 10 is described in connection with a C. difficile preventive murine model, but Henn’s disclosure is not limited to that model. Henn et al. separately and expressly teaches that compositions comprising Table 10 network ecologies may be effective for reducing signs or symptoms of infection or dysbiosis associated with VRE. Accordingly, a person of ordinary skill in the art would not have viewed Table 10 compositions as limited only to C. difficile treatment, but rather as disclosed network ecology compositions contemplated by Henn et al. for VRE-associated dysbiosis or infection.
Fourth, applicant’s reliance on post-filing Caballero data does not overcome the prima facie case. Claim 1 is broad and does not require the particular mechanism discussed in Caballero, restoration of colonization resistance, a specific animal model, a specific dosing regimen, or any particular interaction by which C. bolteae promotes B. producta colonization. Evidence that later work may have further characterized the combination does not render the broadly claimed method nonobvious where Henn et al. already disclosed the claimed bacterial combination and provided a reason to use Table 10 network ecology compositions for VRE-associated infection or dysbiosis. Predictabilty is determined at the relevant time (see MPEP 2143.02). Moreover, applicant has not shown that the alleged unexpected results are commensurate in scope with claim 1. Claim 1 is not limited to the specific experimental conditions, bacterial ratios, model system, or measured VRE CFU reductions discussed in Caballero. Accordingly, the Caballero evidence does not outweigh Henn’s teachings as applied to the full breadth of claim 1.
Finally, with respect to the claimed reduction of “a biomarker” of VRE infection, claim 1 does not identify any particular biomarker, require any specific assay, or require reduction of a particular molecular marker. Under the broadest reasonable interpretation, the claim encompasses reduction of any detectable indicator associated with VRE infection. Henn et al. teaches reducing pathogenic bacteria in the gastrointestinal tract and provides VRE-associated teachings, and it also teaches microbiome analysis using 16S sequencing to identify biomarkers and select compositions for administration. Therefore, where VRE burden or colonization is reduced, a person of ordinary skill in the art would have reasonably expected a corresponding reduction in at least one detectable indicator associated with VRE infection. Applicant has not identified any claim language requiring a narrower biomarker or any particular biomarker whose reduction would not reasonably follow from reduced VRE burden.
Applicant’s arguments with respect to claim 38 have also been fully considered and found to be persuasive. Claims 38 depends from claim 1and further requires that the composition comprises Bacteroides sartorii. The prior rejection relied on Henn et al. for disclosure of Bacteroides vulgatus and Clavel et al. for teaching that B. sartorii is closely related to B. vulgatus. However, upon further consideration, the present record does not sufficiently establish that a person of ordinary skill in the art would have had a reason to modify the relied upon Henn composition to further include B. sartorii with a reasonable expectation of success in reducing the amount of a biomarker of VRE infection in a subject, as claimed. Accordingly, the rejection of claim 38 over Henn et al., further in view of Clavel et al. is withdrawn.
Accordingly, applicant’s arguments as a whole have been fully considered and have been found to be persuasive with respect to claim 38, but are not persuasive and do not overcome the rejection of claim 1 under 35 U.S.C. 103. Therefore, the rejections of claims 1, 3-5, 8, 11-20, 39-44 are maintained.
Conclusion
No claim is in condition for allowance.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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