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 .
Priority
The present application was filed July 18, 2022and is a CON of 16/620,376, filed on December 06, 2019, which is a 371 of PCT/US2018/036742 filed on 06/08/2018 which claims benefit of provisional applications 62/637882 filed on 03/02/2018 and 62/517069 filed on 06/08/2017.
Response to Arguments
Applicant argues that the prior art does not teach the combination Bifidobacterium breve and Clostridium butyricum. Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection necessitated by amendment.
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.
Claims 13-14, 16, 18-20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Glagau (DE Publication No. 10206995A1) in view WO 2009027753 in further view of Shi, Y., Xu, LZ., Peng, K. et al. Specific immunotherapy in combination with Clostridium butyricum inhibits allergic inflammation in the mouse intestine. Sci Rep 5, 17651 (2015). https://doi.org/10.1038/srep17651.
The citation “DE10206995A1_A1_Translation” on form 892 includes the original document and the machine translation of DE10206995.
Regarding claim 13, Glagau discloses, “According to the invention, the micronutrient combination product containing probiotics comprises at least a separately present first product comprising, as active ingredients, probiotic cultures… and at least a second separately present product comprising, as active ingredients…vitamin D” (Para 0027).Glagau discloses that the micronutrient can be vitamin D3 ;4-6μg [first amount of a vitamin D compound], and the probiotic dose can be 5×10 8 - 5×10 9 CFU [second amount of a vitamin D compound], (Para 0040-0043). Vitamin D3 is a species of the genus of “Vitamin D compounds”. Therefore, the species anticipates the genus, “Vitamin D compounds”. See MPEP § 2131.02 Genus-Species Situations I. A Species Will Anticipate A Claim to a Genus, which states that "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.”. This meets the claim limitations of “a composition comprising a first amount of a Vitamin D compound and a second amount of a probiotic compound”. Glagau discloses the probiotic compound can comprise Bifidobacterium, Lactobacillus and Bacillus cereus among other lactic acid bacteria to increase absorption (Para 0011).
Glagau further discloses, “The micronutrient product containing probiotics according to the invention is particularly useful for the dietary treatment of disorders, complaints, or diseases selected from the group comprising: Allergies such as atopic eczema, allergic asthma, allergic rhinitis, food allergy [Atopic disorders]; gastroenteritis; lactose intolerance; inflammatory bowel diseases such as ulcerative colitis” [non-atopic conditions] (Para 0038).
Although Glagau suggests Bifidobacterium, Glagua does not specifically teach Bifidobacterium breve as part of the second amount of a probiotic compound. Further, Glagua does not teach inclusion of Clostridium butyricum.
WO2009027753 teaches a composition for inhibiting inflammation including asthma, sinusitis, Chron’s, reflux disease. Probiotic microorganisms or their derivates, which confer a beneficial health effect on the host organism Lactobacillus, Streptococci and Bifidobacterium species. Specifically the composition comprises probiotic including Bifidobacterium breve and Lactobacillus rhamnosus.
Shi et al (2015) teaches probiotics improve immunity in the body. Shi teach Clostridium butyricum in the treatment of non-atopic conditions (food allergy, allergic inflammation in mouse intestine and inflammatory bowel disease ). See abstract and results.
It would have been prima facie obvious to a person with ordinary skill in the art at the time of filing to modify the probiotic composition of Glagau to include Bifidobacterium breve and Clostridium butyricum as taught by WO ‘753 and Shi respectively. One would have been motivated to do so since Glagau teaches treating allergic conditions such as atopic eczema, as well as non-atopic conditions such as gastroenteritis, diarrhea, and lactose intolerance with vitamin D and probiotics including Bifidobacterium and Lactobacillus and both WO and Shi teach probiotics such as Bifidobacterium breve and Clostridium butyricum for immune modulation and teach similar disorders. It is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form athird composition to be used for the very same purpose... (See MPEP § 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness A. Combining Prior Art Elements According to Known Methods To Yield Predictable Results).
Regarding claim 14, as mentioned above, Glagau discloses that the mineral can be Vitamin D3. Therefore, the claim is obvious for the same reasons as claim 13.
Regarding claim 16, As mentioned above in the rejection of claim 13, Glagau states, “the probiotic dose can be 5×10 8 - 5×10 9 CFU (Para 0041). The prior art range lies entirely within the claimed range of 1.2M CFU or more of the probiotic compound. A person with ordinary skill in the art at the time of filing would have found it prima facie obvious to arrive at the claimed range through routine optimization. This is because the prior art range lies entirely within the claimed range. Further, see MPEP § 2144.05 II Routine Optimization, Optimization Within Prior Art Conditions or Through Routine Experiments- which states that, “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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”. Therefore, the claim is obvious for the same reasons as the previous claims.
Regarding claim 18, as discussed above Glagau discloses, “The micronutrient product containing probiotics according to the invention is particularly useful for the dietary treatment of disorders, complaints, or diseases selected from the group comprising: Allergies such as atopic eczema, allergic asthma, allergic rhinitis, food allergy” (Para 0038). As discussed in the rejection of claim 13 above, WO teaches B. breve and Shi et al teach C. butyricum compositions to modulate the immune system. Therefore, one would expect to the combination of the claimed probiotics and vitamin D to treat immune conditions including those claimed for the same reasons as discussed above.
Regarding claim 19, Glagau discloses the composition for the treatment of allergic rhinitis, atopic eczema, and food allergy. WO teaches B. breve and Shi et al teach C. butyricum compositions to modulate the immune system. Therefore, one would expect to the combination of the claimed probiotics and vitamin D to treat immune conditions including those claimed for the same reasons as discussed above.
Regarding claim 20, Glagau discloses use of the composition on non-atopic conditions such as gastroenteritis, lactose intolerance, and inflammatory bowel diseases such as ulcerative colitis (Para 0038). WO teaches B. breve and Shi et al teach C. butyricum compositions to modulate the immune system for sinusitis and GERD. Therefore, one would expect to the combination of the claimed probiotics and vitamin D to treat immune conditions including those claimed for the same reasons as discussed above.
Regarding claim 22, WO teaches the composition comprises probiotic including Bifidobacterium breve and Lactobacillus rhamnosus.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Glagau (DE Publication No. 10206995A1) in view WO 2009027753 in further view of Shi, Y., Xu, LZ., Peng, K. et al. Specific immunotherapy in combination with Clostridium butyricum inhibits allergic inflammation in the mouse intestine. Sci Rep 5, 17651 (2015). https://doi.org/10.1038/srep17651 in further view of Nielsen (WO Publication No. 2005060937A1).
The teachings of Glagua, WO ‘753, Shi et al have been discussed above.
The references do not teach the inclusion of Bacillus subtilus.
Nielsen discloses probiotic compositions in the form of compressed tablets [claim 1] comprising among the suggested probiotic Bacillus Subtilis [Page 6, lines 5-7], Lactobacillus rhamnosus [Page 5, lines 25-35], Bifidobacterium, Clostridium along with a method of use for treating allergy, especially atopic eczema (Page 12, lines 14-25). Nielsen discloses that use of Lactobacillus rhamnosus has demonstrated efficacy in tests for gastrointestinal disorders [Page 1, lines 20-25] and should be included in tablets of the invention (Page 6, lines 10-14). Nielsen further discloses the use of the composition on similar non-atopic conditions of the gastrointestinal including diarrhea, lactose intolerance, and inflammatory bowel disease (Page 12, lines 14-25).
It would have been prima facie obvious to a person with ordinary skill in the art at the time of filing to modify the probiotic composition to include Bacillus subtilis as taught by Nielsen to improve the immune enhancing effects of the composition. One would have been motivated to do so because Bacillus subtilis is a well-known probiotic in the art, and is disclosed by Nielsen in the similar composition used for the same purposes as disclosed by Glagau of treating allergic conditions such as atopic eczema, as well as non-atopic conditions such as gastroenteritis, diarrhea, and lactose intolerance. It is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form athird composition to be used for the very same purpose... (See MPEP § 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness A. Combining Prior Art Elements According to Known Methods To Yield Predictable Results).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Glagau (DE Publication No. 10206995A1) in view WO 2009027753 in further view of Shi, Y., Xu, LZ., Peng, K. et al. Specific immunotherapy in combination with Clostridium butyricum inhibits allergic inflammation in the mouse intestine. Sci Rep 5, 17651 (2015). https://doi.org/10.1038/srep17651 in further view of Clymer (US Publication No. 20090060878A1).
The teachings of Glagua, WO ‘753, Shi et al have been discussed above.
Regarding claim 15, the prior art does not specify that the Vitamin D compound present in the invention comprises from about 1000 IU to 5000 IU.
Clymer discloses “the steps of administering to a human a composition comprising, (a) cholecalciferol [Vitamin D3]; and (b) a probiotic.” (Page 1, para 0008). Clymer further discloses that the “compositions of the present invention may be administered orally…to prevent and treat allergy symptoms” (Page 6, 0093). Clymer discloses administration of “about 450 IU to about 500,000 IU of cholecalciferol [Vitamin D3], per dose of composition.” (Page 1, Field of the Invention).
It would have been prima facie obvious to a person with ordinary skill in the art at the time of filing to modify the probiotic composition of Glagau, disclosed for treating allergic conditions, with the Vitamin D3 concentration disclosed by Clymer, taught to treat allergic symptoms, to improve the immune enhancing effects of the composition. A person with ordinary skill in the art would have found it obvious to optimize the dosage range to improve the probiotic composition by predictable, and well-known methods in the art. See MPEP § 2144.05 II Routine Optimization, Optimization Within Prior Art Conditions or Through Routine Experiments- which states that, “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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Although the dosage disclosed by Clymer is not the exact same as recited by instant claim 15, the instantly claimed range lies entirely within the range of Clymer of “450 IU to about 500,000 IU”. See MPEP § 2144.05 - Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions - which states that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, the claim is obvious for the same reasons as the previous claims. Further, the instant specification does not provide any definition or guidance as to the metes and bounds of “about”. As the prior art range achieves the same result (treatment of allergies), these values are considered to be reasonably interpreted as “about 1000 IU to about 5000 IU”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP § 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent No. 11419882B2 in view of Glagau (DE Publication No. 10206995A1) in view WO 2009027753 and Nielsen (WO Publication No. 2005060937A1) as applied to the 35 U.S.C. 103 rejection of above, which are herein incorporated by reference. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘882 patent claims, “A composition comprising a first amount of a Vitamin D compound and a second amount of a probiotic compound, wherein the probiotic compound comprises Clostridium butyricum.” (Claim 1).
However, the ‘882 patent does not claim the composition comprises Bifidobacterium breve as claimed in claim 1 and other microbes claimed in the dependent claims (Lactobacillus rhamnosus and Bacillus subtilis) as recited in claim 13 of the instant application or the methods claimed.
As mentioned above in the 35 U.S.C. 103 rejection of claim 13, Glagau discloses a similar composition wherein the probiotic compound can comprise lactic acid bacteria (Para 0011) and the claimed vitamin D. As discussed above in the 35 U.S.C. 103 rejection, Glagau discloses the composition for use in treatment of “atopic eczema, allergic asthma, allergic rhinitis, food allergy [Atopic disorders]; gastroenteritis; lactose intolerance; inflammatory bowel diseases such as ulcerative colitis” [non-atopic conditions].
WO2009027753 teaches a composition for inhibiting inflammation including asthma, sinusitis, Chron’s, reflux disease. Probiotic microorganisms or their derivates, which confer a beneficial health effect on the host organism Lactobacillus, Streptococci and Bifidobacterium species. Specifically, the composition comprises probiotic including Bifidobacterium breve and Lactobacillus rhamnosus.
Nielsen discloses probiotic compositions in the form of compressed tablets [claim 1] comprising Bacillus Subtilis [Page 6, lines 5-4], along with a method of use for treating allergy, especially atopic eczema (Page 12, lines 14-25), and similar non-atopic conditions as disclosed by Glagau as discussed in the 35 U.S.C. 103 rejection above.
It would have been prima facie obvious to a person with ordinary skill in the art at the time of filing to modify the probiotic composition of the ‘882 patent to include the claimed microbes since they are well-known probiotics in the art, and are used in the similar probiotic compositions for the same purpose. It is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form athird composition to be used for the very same purpose... (See MPEP § 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness A. Combining Prior Art Elements According to Known Methods To Yield Predictable Results).
Regarding claim 14, the ‘882 patent claims, “The composition of claim 1, wherein the Vitamin D compound comprises a Vitamin D3 compound.” (Claim 2). These are the exact limitations of instant claim 14. Therefore, the claim is obvious..
Regarding claim 15, the ‘882 patent claims, “wherein the first amount of the Vitamin D compound comprises about 1000 IU, about 2000 IU, or about 4000 IU of the Vitamin D compound.” (Claim 3). Instant claim 15 recites, “wherein the first amount of the Vitamin D compound comprises from about 1000 IU to about 5000 IU of the Vitamin D compound.”. The range disclosed by claim 3 of the ‘882 patent lies entirely within, and therefore makes obvious, the instantly claimed range. A person with ordinary skill in the art at the time of filing would have found it prima facie obvious to adapt the prior art ranges to arrive at the instantly claimed range of about 1000 IU to about 5000 IU of the Vitamin D compound for use with the similar composition. MPEP § 2144.05 - Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions - which states that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, the claim is obvious.
Regarding claim 16, the ‘882 patent claims, “The composition of claim 1, wherein the second amount of the probiotic compound comprises about 3M CFU, about 10M CFU, about 1B CFU, or about 10B CFU of the probiotic compound. (Claim 4). Instant claim 16 recites, “The composition of claim 13, wherein the second amount of the probiotic compound comprises about 1.2 M CFU or more of the probiotic compound.”. The range disclosed by claim 4 of the ‘882 patent lies entirely within, and therefore makes obvious, the instantly claimed range. A person with ordinary skill in the art at the time of filing would have found it prima facie obvious to adapt the prior art ranges to arrive at the instantly claimed range of about 1.2 M CFU or more of the probiotic compound. MPEP § 2144.05 - Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions - which states that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, the claim is obvious.
Regarding claim 17, Nielsen teaches probiotic composition for immune purposes can comprise subtilis. Therefore, the claim is obvious.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. TRACHTMAN (WO Publication No. 2015047941A2) is directed towards a probiotic composition for the prophylaxis and treatment of inflammatory bowel disease (IBD) due to bacterial infection, as well as to compositions and methods for the prophylaxis and treatment of irritable bowel syndrome (IBS), travelers' diarrhea (Para 0001); treatment of acute sinusitis caused by haemophilus influenza (para 0068). TRACHTMAN discloses that the probiotics in the invention can include Lactobacillus rhamnosus, Bifidobacterium breve, and Bacillus subtilis (Para 0068).
Conclusion
No claims are allowed.
Correspondence Information
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 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 SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 7-3:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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