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 the Claims
Claims 1, 4, 6, 14, 17, 19-23, 25, 28, 31-33, 36, 38-39, and 48-49 are pending (claim set as filed on 03/26/2026).
Election/Restrictions
Applicant’s election without traverse of Group I, claims drawn to the products (composition and container/kit thereof) in the reply filed on 03/26/2026 is acknowledged.
Method claims 28, 31-33, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, only product claims 1, 4, 6, 14, 17, 19-23, 25, 38-39, and 48-49 are under examination.
Priority
This application is a 371 of PCT/CA2021/051526 filed on 10/28/2021, which has a provisional application no.: 63/106,422 filed on 10/28/2020.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/05/2023, 10/28/2024, and 01/21/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Drawings
The drawings filed on 04/27/2023 have been accepted.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 14, 21, and 39 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 14, the phrase “(and optionally one or more components)” renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention albeit reciting the term optionally. In other words, parenthetical characters may be used to denote, e.g., an abbreviation of phrase but not to describe an intended embodiment as scope of the claim would be unclear (i.e., analogous to using phrases including “such as”, “preferably”, or “or the like”) (MPEP 2173.05(d): Exemplary Claim Language). Deletion of the parenthetical characters would overcome or remediate the rejection. However, note that regarding the recitation of “optionally”, the MPEP 2111.04 states that “a claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”.
Claims 21 and 39 recite the abbreviation of “LPDG” and therefore, it is unclear what the abbreviation stands for. An abbreviation should be preceded in its first occurrence by the specific identity of the entity which said abbreviation is intended to represent. Thereafter, the use of the abbreviation in the claims will be understood.
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 1, 6, 14, 17, 19-23, 25, 38-39, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Visinoni (US 2005/0074422 A1) in view of Postmes (WO 2019/098833 A1) and Naka (US 2006/0134073 A1).
Visinoni’s general disclosure relates to a fixative composition that may be used in histopathology, cytology and immunohistochemistry (see abstract).
Visinoni discloses “there has been an increasing interest concerning alternative fixatives which allow a complete morphological evaluation of the material together with recovery of good quality DNA/RNA/proteins” where the “formalin alternatives can be subdivided into two broad categories: alcohol-based, and non-alcohol based” (see ¶ [0011]-[0014], [0020]).
Regarding the ingredients, Visinoni further teaches “the fixative composition according to the invention may also contain additives and/or auxiliary agents to further improve the efficiency of the fixative. Examples of the additives and/or auxiliary agents to be added are selected from acceptable salts, alcohols, ketones, carboxylic acids, sugars, polymers, aglycons and polyphenols. Suitable salts include calcium carbonate (a phospholipid chelating agent), calcium acetate (a phospholipid chelating agent), EDTA, stagnus chloride (for membrane preservation), Na2HPO4 (for membrane preservation), MgCl2, NaCl and zinc sulphate” (see ¶ [0041]-[0048], [0055]-[0058]). For certain tissue samples the addition of polymers is desirable comprising polyvinyl pyrrolidone, dextran” (see ¶ [0049]).
Regarding claims 20, 22-23, and 25 pertaining to the biological sample, Visinoni teaches the fixative composition can be successfully used to test any material excised from the human or animal body; the material was examined after immersion fixation of the entire organ or part of it, some reduced to small fragments, to simulate a biopsy, others as a specimen normally examined in routine histopathology (see ¶ [0059]-[0070]). Claim interpretation: however, note that these claims recite intended use phrases including “is for preserving a biological sample” or “for use in a method for identifying tumor” which have been considered but does not have patentable weight since it does not limit the structure of the composition.
Regarding claims 38-39 pertaining to the kit or container limitations, Visinoni teaches the fixative composition may be also provided as a kit for fixation where the contents of the first
and second means can be mixed just prior to use to provide a fixative composition (see ¶ [0051]-[0052]). Regarding the “instructions for use”, the MPEP 2111.05 states that the nature of the printed matter on the conventional instructions included with the known composition as a kit does not change the composition in any way and does not result in a new or unobvious composition. Nonfunctional descriptive material cannot render patentable an invention that would have otherwise been unpatentable “where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability” (see MPEP 2111.05).
However, Visinoni does not teach: honey or the salts/additional ingredients or concentrations thereof (e.g., as seen in claims 1, 14, 17, 19, 39, and 49).
Regarding honey, Postmes’ general disclosure relates to the technical field of tissue preservation (see page 4, lines 3-4); and the use of medical grade honey (MGH) based ingredient for the preparation of a composition for preserving human and/or animal tissue (see page 1, lines 4-6, & page 3, lines 24-30, & page 8, lines 27-30). Postmes discusses the state of art and, in particular, discloses “the use of 10% honey as an alternative to formalin in the histological demonstration of connective tissues without the need for amendments to existing laboratory protocols is mentioned. The function of fixation in cellular pathology is to preserve tissues in a life-like condition by preventing both autolysis and putrefaction … honey as a substitute for histology lab use and compatibility with staining - appears to be more a histological fixative” (see pages 1-2, lines 22-2).
Regarding claim 6 pertaining to the free radical scavenger, Postmes teaches the antioxidants present in the honey based preparation may provide the added benefit of further reducing ischemic damage through the removal of free oxygen radicals responsible for cell membrane damage and lipid peroxidation (see page 8, lines 12-19).
Regarding claim 23 pertaining to a biological or tissue sample, Postmes teaches “ovarian tissue preservation and later transplantation represents one of the most promising techniques in the preservation of fertility in particular in the case of cancer patients” (see page 3, lines 7-10).
Regarding claim 1’s limitations, claim 14, and claims 20-21 pertaining the salts and low potassium dextran solution or pH, Naka discloses organ preservation requires preservation of both the structure and function of the organ (see ¶ [0007]). Naka teaches “the low-potassium dextran glucose solution (PERFADEX™, commercially available from VitroLife, Gothenberg, Sweden), and typically comprises 4 mM potassium, 165 mM sodium, 2 mM magnesium, 101 mM chloride, 34 mM phosphate, 2 mM sulfate, 20 mM Dextran-40, and 56 mM glucose, at a pH of about 7.4 and with an osmolality of about 335 mOsm/L” (see ¶ [0056]).
Regarding claims 6 and 17 pertaining to the sugar acid, Naka teaches “the preservation solution may further comprise impermeant anions, e.g., in an amount sufficient to help maintain endothelial integrity and cellular viability. The impermeant anion can be the gluconate anion or the lactobionate anion (see ¶ [0045]) and other common solution comprises lactobionic acid and glutathione (see ¶ [0057], [0055]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to first employ or add honey such as taught by Postmes in the fixative composition of Visinoni. The ordinary artisan would have been motivated to do so is because Postmes suggests that honey could be used as a substitute for histology lab use and compatibility with staining and for the preparation of a composition for preserving human and/or animal tissue. The ordinary artisan would have had a reasonable expectation of success because both references are directed to alternatives to formalin as fixation compositions.
Furthermore, it would have been secondly obvious to employ or use the organ preservation solutions (e.g., University of Wisconsin solution, Perfadex, Celsior solution, et al.) such as taught by Naka in the fixative composition of Visinoni. Naka discloses well-known organ preservation solutions including low-potassium dextran glucose solution which also comprises common and well-known physiological acceptable salts. The ordinary artisan would have had a reasonable expectation of success is because, as discussed above, Visinoni teaches “the fixative composition according to the invention may also contain additives and/or auxiliary agents to further improve the efficiency of the fixative. Examples of the additives and/or auxiliary agents to be added are selected from acceptable salts”.
Regarding claims 19, 38, and 49 pertaining to the concentrations of the ingredients, if not expressly taught by the references, based upon the overall objective provided by the references with respect maximizing the structure or integrity of the tissues, the adjustments of particular conventional working conditions (e.g., concentration of the ingredients) is deemed a matter of judicious selection and routine optimization which is within the purview of the skill artisan. Therefore, the disclosure of Naka establishes the conditions of variable parameters such that one of ordinary skill in the art would recognize that concentration is a result effective variable dependent upon the type of biological sample to be examined or preserved. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
Claims 4, 21, 39, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Visinoni in view of Postmes and Naka as applied to the claims above, and in further view of Rajanikanth (Transit Fixatives: An Innovative Study, 2015 - cited in the IDS filed on 10/05/2023).
The teachings of Visinoni, Postmes, and Naka are discussed above as it pertains to a fixative composition comprising honey, dextran, sodium, potassium, chlorine, magnesium, sulfate, phosphate, calcium, and bicarbonate.
Regarding claim 4 pertaining to the honey source, Postmes teaches the medical grade honey (MGH) “is Manuka honey, i.e., honey from the nectar of the Manuka tree, also known as active Manuka honey” (see Postmes at page 5, lines 6-19).
However, the combined references do not teach: coconut oil or concentration thereof (as seen in claims 4, 21, 39, and 48).
Rajanikanth discloses “In certain situations, there might be unavailability of formalin and valuable tissue specimens are discarded due to unavailability of formalin or due to lack of knowledge regarding importance of biopsy. For such situations, we intend to find out an alternate solution that can be used for preserving tissues, before it is transferred to formalin to the nearby histopathology lab” (see page 1, left col.). Rajanikanth teaches “the study included commonly available solutions like Spirit, Saline, Betadine solution, Hydrogen peroxide (H2O2), Local anesthesia (L.A), Rose water, Coconut oil, Coconut water, Ice cold water, Honey and Milk while keeping formalin as control” (see abstract). Rajanikanth teaches “Among the transit fixatives investigated, the Honey, L.A., H2O2, coconut oil has all the novel qualities to act as good transit media” (see page 2, right col.).
It would have been obvious to add, combine, or use coconut oil such as taught by Rajanikanth in the fixative composition of the combined references. The ordinary artisan would have been motivated to do so is because Rajanikanth suggested that coconut oil was highly scored or rated as a fixative compound. Thus, the idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06) and an additive effect would have been beneficial for fixation.
Conclusion
No claims were allowed.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653