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 .
A preliminary amendment filed 05/09/2025 amended claims 1-20 and canceled claim 21.
Claims 1-20 are currently pending and have been examined on their merits.
Claim Objections
Claim 8 is objected to because of the following informalities:
The acronyms Col I and Col III in line 2 of the claim should be spelled out that their first occurrence in the claims for purposes of form and clarity (i.e. "collagen I: collagen III (Col 1: Col III)").
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claim 13 is 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 13 recites the limitation "the prebiotic" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of a prebiotic in parent claims 10 and 1.
Appropriate correction is required.
For examination purposes claim 13 will be interpreted as if it were dependent upon claim 12 which does recite a prebiotic.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, and 8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Burcelin et al (US 2014/0348796, hereinafter referred to as Burcelin ‘796, published 11-27-2014).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1, 3, 4, Burcelin '796 claim a method of treating myocardial infarction in a mammal comprising administering to a mammal in need the bacterium Lactobacillus salivarius (page 14 claim 10). Since this method is treating a cardiac dysfunction with the claimed bacterium it is deemed to include an effective amount.
Regarding claim 8, Burcelin '796 are silent with regard to the effect of the method on the expression ratio of Col : Col III, however Burcelin is carrying out the same active method steps as those claimed by Applicant and is therefore deemed to inherently have the same effect.
Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on /n re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, the claims are drawn to an invention employing the same process steps and therefore the effect on the expression ratio of Col I : Col III is deemed to be the same.
Therefore, the teaching of Burcelin '796 anticipates Applicant's invention as claimed.
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.
Claim(s) 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burcelin et al (US 2014/0348796, hereinafter referred to as Burcelin ‘796).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 9, Burcelin '796 teach the method of claim 1 as described above and further include wherein the mammalian subjects ingest a high fat diet (page 3 para 61-72, page 6 para 110).
Regarding claim 10, Burcelin '796 teach wherein the subject is human (page 5 para 107).
Regarding claims 14-18, Burcelin '796 teach wherein the bacterium is administered as a food product, dietary supplement or medicament (pharmaceutical) (page 2 para 31) and as a component in yoghurt (yogurt) (page 5 para 101).
Regarding claim 11, Burcelin '796 teach wherein the product containing the bacterium (dietary supplement) comprises one or more further probiotics (page 2 para 31, page 14 claim 10).
Regarding claims 12-13, Burcelin '796 teach wherein the product containing the bacterium (dietary supplement) comprises a prebiotic, polydextrose (page 11 para 191, para 195, page 14 claim 10, page 15, claims11-12).
Regarding claims 19-20, Burcelin '796 teach wherein the bacterium administered, including Lactobacillus, is at a dosage of 10⁸ to 10¹² CFU of microorganism/dose (page 5 para 101) with ratios of bacterium that allow the claimed Lactobacillus to be present within Applicant's claimed range (page 5 para 105). The lactobacillus bacteria may be present in any ratio capable of achieving the desired therapeutic effect (page 5 para 105).
The specific combination of features claimed is disclosed within the broad genera of mammalian condition, species of Lactobacillus, type of mammal, type of product, type of prebiotic and dosage and administration strategies taught by Burcelin '796, but such "picking and choosing' within several variables does not necessarily give rise to anticipation. Corning Glass Works V. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSA V. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida V. A.G. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (/d.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSA V. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." /d. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of mammalian condition, species of Lactobacillus, type of mammal, type of product, type of prebiotic and dosage and administration strategies from within the disclosure of Burcelin '796 to arrive at methods and compositions "yielding no more than one would expect from such an arrangement".
The motivation and reasonable expectation of success in making these combinations comes from the fact that Burcelin '796 suggests that all these cited variables are suitable for inclusion in their method/composition.
Therefore, the teaching of Burcelin '796 renders obvious Applicant's invention as claimed.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 1, 3-4, 8-20 are rejected under 35 U.S.C. 103 as being unpatentable
over Burcelin (US 2011/0189149, hereinafter referred to as Burcelin '149).
Regarding claims 1, 14-18, Burcelin '149 teach treating cardiovascular disease with a food product, dietary supplement or medicament (pharmaceutical) containing a probiotic (page 2 para 14). This probiotic can include Lactobacillus salivarius (page 4 para 62) and can be a component of yoghurt (yogurt) (page 4 para 69, page 8-9 para 141-142, 145).
Regarding claims 3-4, Burcelin '149 teach that the cardiovascular disease being treated includes myocardial infarction (page 5 para 77, para 83, para 85).
Regarding claim 8, Burcelin '149 are silent with regard to the effect of the method on the expression ratio of Col I: Col III, however Burcelin '149 are carrying out the same active method steps as those claimed by Applicant (administering Lactobacillus salivarius to treat cardiovascular disease) and are therefore deemed to inherently have the same effect.
Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, the claims are drawn to an invention employing the same process steps and therefore the effect on the expression ratio of Col I : Col III is deemed to be the same.
Regarding claim 9, Burcelin '149 teach wherein the mammalian subjects ingest a high fat diet (page 6, para 94).
Regarding claim 10, Burcelin '149 teach wherein the subject is human (page 5 para 73.
Regarding claim 11, Burcelin '149 teach wherein the product containing the bacterium (food product, dietary supplement, or medicament) comprises one or more further probiotics (page 2 para 14).
Regarding claims 12-13, Burcelin '149 teach wherein the product containing the bacterium (dietary supplement) comprises a prebiotic, polydextrose (page 10, para 183- page 11 para 184).
Regarding claims 19-20, Burcelin '149 teach wherein the bacterium administered, including Lactobacillus, is at a dosage of 10⁸ to 10¹² CFU of microorganism/dose (page 4 para 68-72).
The specific combination of features claimed is disclosed within the broad genera of mammalian condition, species of Lactobacillus, type of mammal, type of product, type of prebiotic and dosage and administration strategies taught by Burcelin '149, but such "picking and choosing' within several variables does not necessarily give rise to anticipation. Corning Glass Works V. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSA V. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida V. A.G. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (/d.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR V. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of mammalian condition, species of Lactobacillus, type of mammal, type of product, type of prebiotic and dosage and administration strategies from within the disclosure of Burcelin '149 to arrive at methods and compositions "yielding no more than one would expect from such an arrangement".
The motivation and reasonable expectation of success in making these combinations comes from the fact that Burcelin '149 suggests that all these cited variables are suitable for inclusion in their method/composition.
Therefore, the teaching of Burcelin '149 renders obvious Applicant's invention as claimed.
Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burcelin (US 2011/0189149) as applied to claims 1, 3-4, 8-20 above, and further in view of Klaenhammer et al (US 2013/0224153).
Regarding claims 5-7, Burcelin '149 renders obvious Applicant's invention as described above.
Burcelin '149 does not specifically mention wherein the cardiac dysfunction being treated includes dilated cardiomyopathy or inflammatory heart diseases such as endocarditis and myocarditis.
Klaenhammer teach methods and composition for treating inflammatory disorders by administering a composition comprising a recombinant bacterium (abstract, page 1 para 6). The composition can also include a probiotic, such as Lactobacillus salivarius (page 3 para 23, 26). The inflammatory disorders to be treated include heart diseases, such as myocardial infarction, endocarditis, dilated cardiomyopathy and myocarditis (page 9 para 74).
One of ordinary skill in the art would have been motivated to include treating inflammatory heart diseases, such as dilated cardiomyopathy, endocarditis and myocarditis in the method of Burcelin '149 because Klaenhammer teach that these disorders can be treated with bacterium such as Lactobacillus salivarius and Burcelin '149 is treating inflammatory muscle conditions with Lactobacillus salivarius as well. One of ordinary skill in the art would have had a reasonable expectation of success because bot Burcelin '149 and Klaenhammer teach that suitable inflammatory muscle conditions for inclusion in their method include myocardial infarction.
Therefore, the combined teachings of Burcelin '149 and Klaenhammer et al render obvious Applicant's invention as claimed.
Claims 1-4, 8-20 are rejected under 35 U.S.C. 103 as being unpatentable
over Burcelin (US 2011/0189149) in view of Olmstead et al (US 2014/0079676).
Regarding claims 1-4 and 8-20, Burcelin '149 renders obvious Applicant's invention as described above.
Burcelin '149 does not include a specific embodiment with Lactobacillus salivarius Ls-33.
Olmstead teach methods of treating obesity related disorders that include heart disease, including myocardial infarction, by administering probiotic compositions (pages 2-3, para 13 and para 27). The preferred probiotics include L. salivarius Ls-33 which are well known to those skilled in the art (page 4 para 41).
One of ordinary skill in the art would have selected Lactobacillus salivarius from the list of potential probiotics in the method of Burcelin '149 because Olmstead suggest that this is a suitable and beneficial species of probiotic for use in the treatment of disorders such as myocardial infarction (cardiovascular disease). One of ordinary skill in the art would have selected Lactobacillus salivarius Ls-33 as the strain for use in the method of Burcelin '149 because Olmstead teach that this strain is preferred because it is well known to those skilled in the art of treating obesity related diseases such as heart disease. One of ordinary skill in the art would have had a reasonable expectation of success because both Burcelin '149 and Olmstead suggest using lactobacillus salivarius for the treatment of heart disease such as myocardial infarction.
Therefore, the combined teachings of Burcelin '149 and Olmstead et al render obvious Applicant's invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burcelin et al., (US 2012/0107291), "Bifidobacteria for Treating Diabetes and related Conditions".
Burcelin ‘291 disclose methods of treating cardiac conditions and include Lactobacillus salivarius as a suitable probiotic to include (abstract, para 95).
Burcelin et al., (WO 2010/146568), "Bifidobacteria for Treating Diabetes and related Conditions".
Burcelin ‘568 disclose methods of treating cardiac conditions and include Lactobacillus salivarius as a suitable probiotic to include (abstract, page 14 line 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
