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 .
Information Disclosure Statement
The information disclosure statement dated 9 June 2023 does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Election/Restrictions
Claims 14-16, 22, and 23 are pending in the instant application. Claims 17-21 and 24-26 were canceled by Applicant’s amendment. Applicant’s election without traverse of Group I, Claims 14 and 15, in the reply filed on 20 January 2026 is acknowledged. Claims 16, 22, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 14 and 15 are being examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 14 and 15 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 14 and 15 are drawn to a composition formed entirely from natural ingredients (as disclosed on pages 22-23, paragraph [0066] of the instant specification) including compounds S1, S2, S3, S4, or S9 extracted from sea cucumber ovary and a pharmaceutically acceptable carrier (e.g., water, as disclosed on pages 15-16, paragraph [0030] of the instant specification). The claimed composition is not markedly different from the naturally-occurring counterparts, such as the entire sea cucumber or the sea cucumber ovary as a whole which is known as a culinary delicacy (as disclosed on page 1, paragraph [0002] of the instant specification) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring sea cucumber ovary or pharmaceutically acceptable carrier such as water (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitation “therapeutically effective amount” is not in reference to any specific purpose and therefore encompasses any amount of the compounds S1, S2, S3, S4, or S9.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring sea cucumber ovary or pharmaceutically acceptable carrier such as water (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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 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.
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.
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhao et al. (CN 107699359 A, Translation, 8 pages).
The instant claims are as of record, drawn to a composition comprising a compound represented by S1, S2, S3, S4, or S9 and a pharmaceutically acceptable carrier.
Zhao et al. teach an extraction technique of sea cucumber intestines and eggs (ovary; gonad, see e.g., Zhao et al., page 2, para. 2; as required for instant Claim 14), wherein the intestines and eggs are extracted with 95% ethanol (Zhao et al., page 3; as required for instant Claims 14 and 15). The resulting extract is mixed with vegetable oil (pharmaceutically acceptable carrier; as required for instant Claim 14) and used to fill a soft capsule (therapeutically effective amount; Zhao et al., page 3; as required for instant Claim 14).
Although Zhao et al. teach each of the ingredients of the claimed composition, they are
silent regarding the specific recited compounds i.e. compound represented by S1, S2, S3, S4, or S9. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the sea cucumber ovary extracts of the prior art are the same as those of the instant invention. The extract of the instant invention is prepared via extraction with 45-85% ethanol (instant specification, [0012]), and the compound represented by S1, S2, S3, S4, or S9 were subsequently fractionated from this extract, and thus it is reasonable to expect than an ethanolic extract of sea cucumber ovary would comprise compounds represented by S1, S2, S3, S4, or S9, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the composition of the instant invention and that of the prior art is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses ethanolic extraction of sea cucumber eggs, which appears to be identical to the presently claimed composition since it is formulated and/or obtained from the same component materials and using the same solvents. Consequently, the claimed composition appears to be anticipated by the reference. In the alternative, even if the composition is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and extraction method). Thus, the claimed composition would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhang et al. (CN 106491989 B, Translation, 11 pages).
The instant claims are as of record, drawn to a composition comprising a compound represented by S1, S2, S3, S4, or S9 and a pharmaceutically acceptable carrier.
Zhang et al. teach a preparation method of a composition for anti-aging comprising drying sea cucumber internal organs, crushing, and then extraction with 30-70% ethanol (Zhang et al., page 5; as required for instant Claims 14 and 15). The sea cucumber internal organs comprise the gonad (ovary; Zhang et al., page 4; as required for instant Claim 14). Additionally, the composition can be made into a capsule comprising corn starch (pharmaceutically acceptable carrier; Zhang et al., page 7; as required for instant Claim 14).
Although Zhang et al. teach each of the ingredients of the claimed composition, they are
silent regarding the specific recited compounds i.e. compound represented by S1, S2, S3, S4, or S9. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the sea cucumber ovary extracts of the prior art are the same as those of the instant invention. The extract of the instant invention is prepared via extraction with 45-85% ethanol (instant specification, [0012]), and the compound represented by S1, S2, S3, S4, or S9 were subsequently fractionated from this extract, and thus it is reasonable to expect than an ethanolic extract of sea cucumber ovary would comprise compounds represented by S1, S2, S3, S4, or S9, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the composition of the instant invention and that of the prior art is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses extraction of sea cucumber internal organs, including gonads, with 30-70% ethanol, which appears to be identical to the presently claimed composition since it is formulated and/or obtained from the same component materials and using the same solvents. Consequently, the claimed composition appears to be anticipated by the reference. In the alternative, even if the composition is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and extraction method). Thus, the claimed composition would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655