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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on August 14, 2026.
Restrictions/Elections.
Applicant's election with traverse of Group I (Claim 1) in the reply filed on August 14, 2026, is acknowledged.
The traversal is on the ground(s) that Groups I and II overlap. This is not found persuasive because a lipid lowering method does not necessarily overlap with a hepatoprotection method.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-3 are currently pending and are the subject of this office
action.
Claims 2-3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant timely traversed the restriction (election) requirement in the reply filed on August 14, 2026.
Claim 1 is presently under examination.
Priority
The present application is a CIP of PCT/CN2023/077120 filed on 02/20/2023 and claims priority to foreign application CHINA CN202210194670 filed on 03/01/2022.
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.
1) Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bannister et. al. (US 2012/0270899).
For claim 1, Bannister teaches a method of treating hyperlipidemia and dyslipidemia (i.e. high blood lipid level) comprising the administration of a pharmaceutical composition comprising a therapeutic compound that has an activity that normalizes lipid levels and a pharmaceutically acceptable solvent, wherein the solvent can comprise arabitol (arabitol is being interpreted as a racemic mixture of D-arabitol and L-arabitol, which anticipates a composition comprising D-arabitol) (see claims 162-163 and 208-209, and paragraphs [0004], [0118], [0287] and [0063]).
The prior art does not mention that D-arabitol is an “active ingredient”. However, the fact that D-arabitol is an “active ingredient” seems to be an inherent property of D-arabitol.
MPEP 2112 I states:
“The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function (i.e. active ingredient) or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112 III recites:
“Where applicant claims a composition in terms of a function, property or characteristic (i.e. active ingredient) and the composition of the prior art is the same as that of the claim, but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.”
MPEP 2112 V recites:
“The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
MPEP 2112.01 II states:
"Products of identical chemical composition (i.e. D-arabitol) cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses (I.e. active ingredient) and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."
2) Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turner et. al. (US 2016/0263170).
For claim 1, Turner teaches a method of treating dyslipidemia (i.e. high blood lipid level) comprising the administration of a pharmaceutical composition comprising arabitol (arabitol is being interpreted as a racemic mixture of D-arabitol and L-arabitol, which anticipates a composition comprising D-arabitol) (see claims 21-22, 12, 9, 18 and 20; see also paragraphs [0088], [0097] and [0101]).
The prior art does not mention that D-arabitol is an “active ingredient”. However, the fact that D-arabitol is an “active ingredient” seems to be an inherent property of D-arabitol.
MPEP 2112 I states:
“The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function (i.e. active ingredient) or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112 III recites:
“Where applicant claims a composition in terms of a function, property or characteristic (i.e. active ingredient) and the composition of the prior art is the same as that of the claim, but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.”
MPEP 2112 V recites:
“The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
MPEP 2112.01 II states:
"Products of identical chemical composition (i.e. D-arabitol) cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses (I.e. active ingredient) and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."
3) Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammam et. al. (Journal of Pharmaceutical, Chemical and Biological Sciences (2016) 4:76-87).
For claim 1, Hammam teaches a method of treating hyperlipidemia (i.e. high blood lipid level) comprising the administration of a pharmaceutical composition comprising a seed ethanol extract of Moringa Oleifera (MO) (See abstract), wherein the seed ethanol extract of Moringa Oleifera (MO) comprises D-arabitol (See Table 3 on page 81)
The prior art does not mention that D-arabitol is an “active ingredient”. However, the fact that D-arabitol is an “active ingredient” seems to be an inherent property of D-arabitol.
MPEP 2112 I states:
“The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function (i.e. active ingredient) or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112 III recites:
“Where applicant claims a composition in terms of a function, property or characteristic (i.e. active ingredient) and the composition of the prior art is the same as that of the claim, but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.”
MPEP 2112 V recites:
“The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).
MPEP 2112.01 II states:
"Products of identical chemical composition (i.e. D-arabitol) cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses (I.e. active ingredient) and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 14, 2026.
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