DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group III, claims 36-39 in the reply filed on 6 November 2025 is acknowledged. Claims 1-22, 24-30, 32-35, and 40-45 have been withdrawn. Claims 36-39 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/0192100, filed February 23, 2021, which claims priority to U.S. Provisional Application No. 62/981829, filed February 26, 2020.
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.
Claims 36-39 are 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.
In claim 36, the use of the phrase "and/or" multiple times in the claimed composition is indefinite, because it creates multiple alternatives and, thus, it is uncertain what is intended for the fluid as claimed.
Additionally regarding claim 36, the limitation “live fish cells, tissues, or organs” is indefinite, because as currently written, it is unclear if only the cells are required to be live and from fish, or instead, if all of the cells, tissues, and organs are intended to be live and from fish.
Claims 38 and 39 are likewise rejected for recitation of “live fish cells, tissues, or organs.”
The term “prolong” in claim 38 is a relative term which renders the claim indefinite. The term “prolong” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what amount of time is intended to be included in, or excluded from, “prolonging” viability.
Further, as the metes and bound of prolonging viability are unclear, it is also unclear what amount of the at least one factor may be considered an “amount effective” to prolong viability.
Additionally regarding claim 38, this claim appears to indicate that the fluid of claim 36 alone is not sufficient to prolong, which is to preserve, viability. However, independent claim 36 claims that the fluid is “suitable for… preserving” the live fish cells, tissues, or organs. This claim is indefinite, because is it unclear if Applicant intends the at least one factor of claim 37 to further increase the time the live fish cells, tissues, or organs remain viable over that of just the fluid in claim 36, or instead, if Applicant is intending to indicate that the fluid alone is insufficient to preserve viability. It is noted that if Applicant intends to convey that the fluid of claim 36 is not suitable for preserving viability, claim 38 would be subject to rejection under 112(d), and claim 36 would potentially lack enablement under 112(a)).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Independent claim 36 claims a fluid that is suitable for preserving and/or storing live fish cells, tissues, or organs, and claim 37 then indicates that the fluid comprises at least one factor selected from a group that includes water. Claim 39, which depends from 36 and 37, fails to include all the limitations of the claims upon which it depends. As currently written, the fluid with the at least one factor preserves and/or prevents damage to the live fish cells, tissues, and organs for an extended period of time as compared to maintenance/storage “in water alone.” However, in claim 37, water is included in “at least one factor.” As the fluid including at least one factor can be water per claims 36 and 37, claim 39 fails to include all the limitations of the claims upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 36-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a fluid suitable for contacting, perfusing, preserving, and/or storing live fish cells, tissues, or organs. This judicial exception is not integrated into a practical application because the fluid comprises water, including sea/ocean water. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only a fluid that can be water is claimed.
With regard to Step 1, the fluid as claimed in claim 36 is a composition of matter.
With regard to Step 2A, prong one, claim 36 encompasses a fluid suitable for contacting, perfusing, preserving, and/or storing live fish cells, tissues, or organs. It is indicated in the Specification that the fluid comprises water, including spring water, ocean water, sea water, or lake water (Spec., para. 62). As such, the fluid of claim 1 is deemed to encompass water, which is a natural product.
With regard to Step 2A, Prong two, claim 36 does not recite any elements in addition to the fluid that encompasses water. As such, there is no additional element in claim 36 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the natural fluid, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
With regard to Step 2B, claim 1 does not recite any elements in addition to the fluid. As such, the claim does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Dependent claim 37 further indicates that the fluid contains at least one factor including water and/or salts. As such, this claim does not recite any elements in addition to the fluid that encompasses water, including sea/ocean water.
Dependent claims 38 and 39 further characterize water, including sea/ocean water. As such, these claims do not recite any elements in addition to the fluid that encompasses water, including sea/ocean water.
For the forgoing reasons, the fluid as claimed is not deemed to encompass patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 102
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.
Claims 36-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakurai et al. (IDS; JP 2010104356, Published 2010; Translation provided by Examiner and referred to hereafter), as evidenced by Wikipedia (Seawater, Accessed 11/24/2025, Available online at: en.wikipedia.org/wiki/Seawater).
With regard to claims 36 and 37, Sakurai et al. teach an irrigation fluid made of seawater, the irrigation fluid suitable for contacting, irrigating which is perfusing, retaining freshness which is preserving, and storing fish (Abs.), wherein seawater comprises water and salts (see Wikipedia, para. 1). The irrigation fluid is perfused into blood vessels of live fish and circulated (Abs.; claims). Thus, the irrigation fluid is suitable for contacting, perfusing, preserving, and/or storing live fish cells, tissues, or organs.
With regard to claim 38, as discussed above, Sakurai et al. teach irrigation fluid made of seawater, wherein seawater comprises water and salts. As the water and salts in the seawater of Sakurai et al. cannot be separated from their properties, and as Sakurai et al. specifically teach that the irrigation fluid is suitable for preserving the freshness of the fish, the water and salts in the seawater are necessarily present in an amount effective to provide the result of prolonging the viability of the fish cells, tissues, or organs when maintained substantially in the fluid, as compared to the maintenance of fish cells, tissues, or organs stored in the fluid alone.
With regard to claim 39, as discussed above, Sakurai et al. teach irrigation fluid made of seawater, wherein seawater comprises water and salts. As the water and salts in the seawater of Sakurai et al. cannot be separated from their properties, the irrigation fluid of Sakurai et al. necessarily provides the results of preserving and/or preventing damage to the live fish cells, tissues, and organs for an extended period of time as compared to the maintenance and/or storage of the live fish tissue, cells or organs maintained in water alone.
Conclusion
No claims are allowable.
Art of Record:
Won et al., KR 2005/0017568A, Published 2005 (ice-cold sea water for storing and transporting live squid).
Dagbjartsson et al., Icelandic experience in storing fish in chilled seawater, Abstract, International Journal of Refrigeration, Vol. 5, Iss. 3, (May 1982), pp. 141-145 (chilled seawater for storage of eviscerated or ungutted fish).
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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