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 .
Claims 12, 16, 17 and 20-25 are pending in this application and were examined on their merits.
The rejection of Claims 12 and 16 under 35 U.S.C. § 102(a)(1) as being
anticipated by Burcelin et al. (WO 2010/146568 A2), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 10/10/2025.
The rejection of Claim(s) 12 and 16 under 35 U.S.C. § 102(a)(1) as being anticipated by Burcelin et al. (WO 2011/013106 A1), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 10/10/2025.
Claim Interpretation
The preamble of Claim 12 now recites, “for preventing obesity-related diseases…”. The Disclosure does not define the term “preventing”, so it has been accorded its broadest, reasonable interpretation of “an attempt to prevent disease”.
See NCI (2025) which defines “prophylaxis” which is a synonym for “prevention” in the context of disease.
With regard to the preamble of Claim 12, which now recites: “by reducing energy
intake or fat intake or a combination of the energy intake and the fat intake”, this is a statement of intended use which does not materially or manipulatively differentiate the claimed method from that of the prior art and is therefore not given patentable weight. See the MPEP at 2111.02, Il. If the method of the prior art administers the same bacterium to a mammal in an attempt to prevent disease (as construed above) the same results would be expected, and it would anticipate the claimed invention.
claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 12, 16, 17 and 20-25 are newly rejected under 35 U.S.C. § 103 as being
unpatentable over Burcelin et al. (WO 2010/146568 A2), of record.
The teachings of Burcelin et al. were discussed above.
Burcelin et al. teaches a method of controlling weight gain, inducing weight loss
and lowering body fat mass in a mammal by administering Bifidobacterium animalis subspecies Lactis strain 420 (B420) in combination with the prebiotic polydextrose (Pg. 51, Claims 45, 54, 55 and 57 and Pg. 53, Claims 61 and 62);
the reference further teaches that the dose of microorganism can be about 106 to about 1012 CFU/dose (Pg. 15, Lines 16-19), and reading on Claims 12 and 16.
With regard to the preamble of Claim 12, which specifies “a mammal without diagnosed metabolic diseases or having not use of related medications”, the mammal of Burcelin et al. whom is being treated regarding the conditions of: controlling weight gain, inducing weight loss and lowering body fat mass would meet the claimed limitations as “weight” and “body fat mass” are not diagnosed metabolic diseases and the prior art claims do not require the mammal be treated with any related medications.
With regard to Claims 12 and 25, which recited respectively “for preventing obesity-related diseases”, “by reducing energy intake or fat intake or a combination of the energy intake and the fat intake” and “wherein the obesity related diseases being prevented comprises one or more of the following diseases, high blood pressure, diabetes, heart diseases, high cholesterol levels, cancer or infertility”; as Burcelin et al. administers the same bacterial strain to the same mammalian subject as claimed, the same results (e.g., reducing energy intake, fat intake or a combination of the energy intake and the fat intake and prevention of one or more of high blood pressure,
diabetes, heart diseases, high cholesterol levels, cancer or infertility) would be expected.
Burcelin et al. did not teach an anticipatory embodiment wherein the bacterium and polydextrose is administered to the mammal in the form of a food product, a dietary supplement or a pharmaceutically acceptable formulation, as required by Claim 17;
wherein the bacterium is administered in the form of a medical food product, as required by Claim 21;
or wherein the food product is administered in the form of a medicament, as required by Claim 23.
With regard to Claim 17, Burcelin et al. teaches that the claimed composition may be used as a food (Pg. 26, Lines 6-11), may be or added to dietary supplements (Pg. 29, Lines 9-10) or may be used as a pharmaceutical acceptable formulation (Pg. 30, Lines 29-33).
With regard to Claims 20 and 22, Burcelin et al. teaches a method of treating obesity, controlling weight gain, inducing weight loss and lowering body fat mass in a mammal by administering Bifidobacterium animalis subspecies Lactis strain 420 (B420) in combination with the prebiotic polydextrose (Pg. 51, Claims 45, 54, 55 and 57 and Pg. 53, Claims 61 and 62).
With regard to Claims 21, 23 and 24, Burcelin et al. teaches that the composition may be added to a nutraceutical which crosses the traditional dividing lines between foods and medicine (e.g., a medical food) (Pg. 29, Lines 30-34) or as a medicament (Pg. 30, Lines 1-11).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Burcelin et al. of a method of
treating obesity, controlling weight gain, inducing weight loss and lowering body fat
mass in a mammal by administering Bifidobacterium animalis subspecies Lactis strain
420 (B420) in combination with the prebiotic polydextrose with the elements separately
taught in the disclosure (administration in the form of a medical food or medicament) of
the reference because this is no more than the combining of separately taught prior art
elements in the same reference according to known methods to yield predictable
results. See the KSR rationale at MPEP at 2143, I., A. Those of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification in order to achieve different aspects of the primary treatment method of Burcelin et al., such as, the composition form and administration route. There would have been a reasonable expectation of success in making this modification because the reference separately teaches all of the prior art claimed elements.
Claim(s) 12, 16, 17 and 20-25 are newly rejected under 35 U.S.C. § 103 as being
unpatentable over Burcelin et al. (WO 2011/013106 A1), of record.
Burcelin et al. (‘106) teaches a method of regulating lipid absorption in a mammal by administering Bifidobacterium animalis subspecies Lactis strain 420 (B420) in combination with the prebiotic polydextrose (Pg. 43, Claim 49 and Pg. 44, Claims 51, 52, 53 and 58-60);
and wherein the strain may be administered in a dosage of about 106 to about 1012 CFU/dose (Pg. 13, Lines 32-33 and Pg. 14, Lines 1-2), and reading on Claims 12 and 16.
With regard to the preamble of Claim 12, which specifies “a mammal without diagnosed metabolic diseases or having not use of related medications”, the mammal of Burcelin et al. (‘106) whom is being treated regarding the condition of regulating lipid absorption would meet the claimed limitations as “lipid absorption” is not a diagnosed metabolic disease and the prior art claims do not require the mammal be treated with any related medications.
With regard to Claims 12 and 25, which recited respectively “for preventing obesity-related diseases” and “wherein the obesity related diseases being prevented comprises one or more of the following diseases, high blood pressure, diabetes, heart diseases, high cholesterol levels, cancer or infertility”; as Burcelin et al. (‘106) administers the same bacterial strain to the same mammalian subject as claimed, the same results (e.g., reducing energy intake, fat intake or a combination of the energy intake and the fat intake and prevention of one or more of high blood pressure,
diabetes, heart diseases, high cholesterol levels, cancer or infertility) would be expected.
The teachings of Burcelin et al. (‘106) were discussed above.
Burcelin et al. did not teach an anticipatory embodiment wherein the bacterium
and polydextrose is administered to the mammal in the form of a food product, a dietary
supplement or a pharmaceutically acceptable formulation, as required by Claim 17;
wherein the bacterium is administered in the form of a medical food product, as required by Claim 21;
or wherein the food product is administered in the form of a medicament, as required by Claim 23.
With regard to Claim 17, Burcelin et al. (‘106) teaches that the claimed composition may be used as a food (Pg. 20, Lines 7-11), may be or added to dietary supplements (Pg. 23, Lines 9-10) or may be used as a pharmaceutical acceptable formulation (Pg. 24, Lines 15-16).
With regard to Claims 20 and 22, Burcelin et al. (‘106) teaches a method of regulating lipid absorption (therefore non-therapeutic) in a mammal by administering Bifidobacterium animalis subspecies Lactis strain 420 (B420) in combination with the prebiotic polydextrose (Pg. 43, Claim 49 and Pg. 44, Claims 51, 52, 53 and 58-60).
With regard to Claims 21, 23 and 24, Burcelin et al. (‘106) teaches that the composition may be added to a nutraceutical which crosses the traditional dividing lines between foods and medicine (e.g., a medical food) (Pg. 23, Lines 24-26 and Pg. 24, Lines 1-2) or as a medicament (Pg. 24, Lines 4-12).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Burcelin et al. (‘106) of a
method of regulating lipid absorption in a mammal by administering Bifidobacterium
animalis subspecies Lactis strain 420 (B420) in combination with the prebiotic
polydextrose with the elements separately taught in the disclosure (administration in the
form of a medical food or medicament) of the reference because this is no more than
the combining of separately taught prior art elements in the same reference according
to known methods to yield predictable results. See the KSR rationale at MPEP at 2143, I., A. Those of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification in order to achieve different aspects of the primary treatment method of Burcelin et al.(106), such as, the composition form and administration route. There would have been a reasonable expectation of success in making this modification because the reference separately teaches all of the prior art claimed elements.
Response to Arguments
Applicant’s arguments, see Remarks, Pgs. 5-17, filed 10/10/2025, with respect to the above withdrawn rejections have been fully considered and are persuasive.
Applicant's arguments regarding the rejection(s) under 35 U.S.C. § 103 filed 10/10/2025 have been fully considered but they are not persuasive.
The Applicant argues that that the Burcelin publication(s) do not teach or suggest the limitations of amended Claim 12 and the Examiner has provided no rationale as to why the ordinary artisan would modify the references to arrive at the claimed invention (Remarks, Pg. 18, Lines 14-18).
This is not found to be persuasive for the reasoning provided in the above new rejections.
The Applicant argues that “prevention” is distinct from “treatment” as they are drawn to different uses and the ordinary artisan would not have a reason to modify one usage to another (Remarks, Pg. 18, Lines 19-26 and Pg. 19, Lines 1-2).
This is not found to be persuasive for the following reasons, as discussed above, the Examiner notes that in the absence of a definition in the disclosure the term “prevention” has been accorded its broadest, reasonable interpretation of “an attempt to prevent disease”. See NCI (2025). The Examiner further notes that both Burcelin (for example, the ‘106 at Pg. 18, Lines 31-32 and Pg. 19, Lines 1-4) references define “treatment” as including:
preventing the specified disease from occurring in an animal which may be predisposed to the disease but does not yet experience or display the pathology or symptomatology of the disease (including prevention of one or more risk factors associated with the disease)
Thus, the ordinary artisan would recognize that the “treatment” of the prior art would encompass the “prevention” of the claimed invention.
The Applicant argues that Burcelin does not suggest that B420 affects appetite, satiety or caloric intake, the ordinary artisan would not have been motivated to use B420 to reduce energy/fat intake in healthy individuals and the mechanism of Burcelin does not imply appetite modulation by reducing fat and/or energy consumption (Remarks, Pg. 19, Lines 3-8 and 34-42).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., administration to healthy individuals and that B420 affects appetite, satiety or caloric intake) are not recited in the rejected claim(s).
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nevertheless, Burcelin discloses administration of B420 for controlling weight gain, inducing weight loss, lowering body fat mass and regulating lipid absorption which are not diagnosed metabolic diseases and the prior art claims do not require the mammal be treated with any related medications. With regard to the limitation, “by reducing energy intake or fat intake or a combination of the energy intake and the fat intake”; as Burcelin et al. administers the same bacterial strain to the same mammalian subject as claimed, the same results (e.g., reducing energy intake, fat intake or a combination of the energy intake and the fat intake) would be expected.
The Applicant argues that Burcelin allegedly discloses effects such as weight-loss, improved glucose tolerance and reduced fat mass but does not disclose or suggest reduction in energy and or fat intake as an outcome. Applicant notes the claims require a causal link between B420 administration and reduced fat/energy intake, not just reduced body fat or weight. Applicant asserts that Burcelin while disclosing B420 administration, does so in the context of disease treatment not for modulating dietary intake in a healthy or general population (Remarks, Pg. 19, Lines 9-17).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., administration to healthy individuals or the general population) are not recited in the rejected claim(s).
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nevertheless, Burcelin discloses administration of B420 for controlling weight gain, inducing weight loss, lowering body fat mass and regulating lipid absorption which are not diagnosed metabolic diseases and the prior art claims do not require the mammal be treated with any related medications. With regard to the limitation, “by reducing energy intake or fat intake or a combination of the energy intake and the fat intake”; as Burcelin et al. administers the same bacterial strain to the same mammalian subject as claimed, the same results (e.g., reducing energy intake, fat intake or a combination of the energy intake and the fat intake) would be expected.
The Applicant argues that Burcelin addresses treatment of metabolic disorders not the physiological modulation of fat and/or energy intake with B420 and the reference does not suggest or motivate such as use (Remarks, Pg. 19, Lines 19-22).
This is not found to be persuasive for the following reasons, Burcelin discloses administration of B420 for controlling weight gain, inducing weight loss, lowering body fat mass or regulating lipid absorption which are not diagnosed metabolic diseases and the prior art claims do not require the mammal be treated with any related medications.
With regard to the limitation, “by reducing energy intake or fat intake or a combination of the energy intake and the fat intake”; as Burcelin et al. administers the same bacterial strain to the same mammalian subject as claimed, the same results (e.g., reducing energy intake, fat intake or a combination of the energy intake and the fat intake) would be expected.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653