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 .
Status of claims
Claims 8 and 10-16 as amended on 5/14/2026 are pending and under examination in the instant office action.
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.
Claims 8, 10-13, 15 and 16 as amended are rejected under 35 U.S.C. 103 as being unpatentable over Hossen et al (Molecular Therapy, 2013, Vol. 3, No. 3 pages 533-541) in view of KR 10-2210764 IDS reference).
The reference by Hossen discloses a method of preventing or ameliorating obesity, wherein the method comprises administering a preparation with cytochrome C (CytC) which belongs to a class of hemoproteins for containing a porphyrin ring complexed with iron or heme-iron as the “hemoprotein” of the instant application and claims (see par. 0011-0012 of published application US 2025/0018013). The reference by Hossen teaches that treatment of cytochrome-loaded nanoparticles resulted in a substantial reduction in obesity of high-fat diet fed mice (see abstract) and ablation of fat mass (page 536, col.1, last line), thus, it reduces fat-to-body weight ratio. The reference by Hossen teaches a hemoprotein cytochrome (CytC) as anti-obesity drug (abstract).
In particular, the preparation with hemoprotein or cytochrome of Hossen is a purified from bovine heart (see materials and methods) but is not a microbial hemoprotein extract.
However, the prior art teaches that a hemoprotein or hemoprotein extract is obtained from a microbial source. See KR 10-2210764 English translation. The cited KR 10-2210764 teaches that hemoprotein from bacteria has the same structure as animal hemoprotein but without a risk of contamination by animal viruses (see English translation, page 1, last par.). In particular, the cited KR 10-2210764 teaches that hemoprotein is extracted from a non-genetically modified microorganism selected through adaptive evolution for growth rate and heme iron productivity to have a higher hemoprotein content than a parent strain (see English translation, page 1, second paragraph of section “description”). The cited KR 10-2210764 teaches that hemoprotein is obtained by a method comprising recovering microbial biomass from the microbial culture broth, resuspending and disrupting the recovered microbial biomass, and centrifuging or drying the resulting suspension (see English translation page 3, second paragraph from the bottom); and it can be provided in a form of microbial culture broth obtained by culturing a heme iron-producing microorganism, microbial biomass isolated therefrom, or a hemoprotein isolated and purified therefrom (see English translation page 3, last paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to substitute a microbial hemoprotein extract for an animal derived hemoprotein in the method of Hossen with a reasonable expectation of success in preventing and ameliorating obesity because administration of hemoprotein provides for a substantial reduction in obesity as taught by Hossen and because hemoprotein from bacteria has the same structure as animal hemoprotein but without a risk of contamination by animal viruses (KR 10-2210764).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-16 rejected under 35 U.S.C. 103 as being unpatentable over Hossen et al (Molecular Therapy, 2013, Vol. 3, No. 3, pages 533-541) in view of KR 10-2210764 IDS reference) as applied to claims 1-11, 13, 15 and 16 above, and further in view of US 11,202,807 (De Vos et al).
The cited reference by Hossen and KR 10-2210764 are relied upon for the teaching of method for preventing or ameliorating obesity by administration of hemoprotein including microbial hemoprotein.
The cited references are silent about gut microbiome health and presence of bacteria Akkermania in intestinal flora of subjects in need preventing or ameliorating obesity.
However, it is well knonw that bacteria Akkermania spp are depleted in intestinal flora of obese subjects when compared to normal or non-obese subject and that level of Akkermania are increased in non-obese fasting subjects (see US 11,202,807 at col. 6, lines 9-24).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to recognize that ameliorating obesity in subject in need therefore result in gut microbiome health and increase of bacteria Akkermania in intestinal flora.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed 5/14/2026 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over Hossen et al (Molecular Therapy, 2013, Vol. 3, No. 3 pages 533-541) in view of KR 10-2210764) Applicants’ main argument is that Hossen does not teach anti-obesity administration of a cytochrome per se but rather as encapsulated form of cytochrome, thereby, teaching away from anti-obesity effect of cytochrome (response page 2).
This argument is not persuasive because the cited reference by Hossen clearly recognizes a potential of hemoprotein cytochrome (CytC) as an anti-obesity drug (see last 2 lines of abstract). The encapsulation of CytC is provided to improve in vivo pharmacokinetics and to overcome rapid clearance of CytC from circulation in the body (see abstract). Thus, primary reference by Hossen clearly teaches and suggests to use a hemoprotein cytrochrome C (or a hemoprotein-containing preparation) as antiobesity drug.
Further, it is well knonw that all living organisms including microorganisms produce hemoprotein (see instant specification page 3, par. 2). Thus, administration of any at all microbial biomass or microbial extract provides for treating obesity.
As applied to instant claims, the cited KR 10-2210764 teaches that hemoprotein from bacteria has the same structure as animal hemoprotein but without a risk of contamination by animal viruses (see English translation, page 1, last par.) and that hemoprotein or heme-iron from microorganisms is a safe source of heme iron (see English translation, page 1, last par, lines 6-7). Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to substitute a microbial hemoprotein extract for an animal derived hemoprotein in the method of Hossen with a reasonable expectation of success in preventing and ameliorating obesity because administration of hemoprotein provides for a substantial reduction in obesity as taught by Hossen and because hemoprotein from bacteria has the same structure as animal hemoprotein but without a risk of contamination by animal viruses (KR 10-2210764).
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila 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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Vera Afremova
July 10, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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