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
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 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.
Response to Amendments
Applicant’s amendments, IDS, and response filed Sept. 25, 2025 have been received and entered into the case.
Status of the Claims
Claims 1-5, 7, 8, 10, 13, 15, 17, 19, 26, 30, 35, 38, and 78-80 are currently pending.
Claim 1 is amended.
Claims 6, 9, 11, 12, 14, 16, 18, 20-25, 27-29, 31-34, 36, 37, 39-44, 48-62 and 64-77 are cancelled.
Claims 78-80 are new.
Claims 1-5, 7, 8, 10, 13, 15, 17, 19, 26, 30, 35, 38, and 78-80 have been considered on the merits.
Claim Objections
Claim 80 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 79. Linolenic acid (18:3) recited in claim 80 is a synonym of linolenic acid recited in claim 79 and linoleic acid (18:2) recited in claim 80 is a synonym of linoleic acid recite in claim 79. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), are withdrawn due to amendment.
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment. New claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ) have been added to address the claim amendments.
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 1-5, 7, 8, 10, 13, 15, 17, 19, 26, 30, 35, 38, and 78-80 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.
Claim 1 is rendered indefinite for containing the phrase, “treating said biological cells transport preservation composition after receipt at said treatment location for hypothermic treatment; hypothermically treating said biological cells”, since it is unclear how exactly the cells are being treated for hypothermic treatment. It is unclear if the treating is hypothermic treatment which is the next recited step in the claim or whether an additional treatment is being done to prepare the cells for hypothermic treatment. For the sake of compact prosecution, the limitation will be interpreted mean “hypothermically treating said biological cells transport preservation composition after receipt at said treatment location
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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.
Claims 1-5, 7, 13, 15, 17, 26, 30, 35, 38 and 78-80 are rejected under 35 U.S.C. 103 as being unpatentable over Herickhoff et al. (US 2010/0068809 A1) (ref. of record)(“Herickhoff (809)”) as evidenced by Guetouache et al. (Journal of Issues Biological Sciences and Pharmaceutical Research, 2014) (ref. of record) and in view of Palecek et al. (US 2005/0106554 A1) (ref. of record), Kravitz et al. (CA 2838537 A1) (ref. of record), and Licari et al. (US 2007/0087320 A1).
With respect to claim 1, Herickhoff (‘809) teaches a method of protecting biological cells in vitro by preserving the cells in a holding medium (0048). With respect to with respect to the first recited step of claim 1, Herickhoff (‘809) teaches harvesting a collection of biological cells from an vivo source (0008, 0040, 0041 and 0050). The harvesting would inherently occur at a location. For instance, Herickhoff (‘809) teaches collecting semen from stallions via artificial vaginas or a harvesting location (Examples 1-4).
With respect to with respect to the second recited step of claim 1, Herickhoff (‘809) teaches preserving the collection of cells based on an anticipated cell damage limiting regimen and a predetermined use (0008-0017 and 0040-0042). Additionally, Herickhoff (‘809) states “an effective amount of extract combined with the sperm cells can vary and be adjusted dependent upon the application, species, volume of ejaculate, or like parameters” or in other words, Herickhoff teaches preserving the cells based on the anticipated cell damage limiting regimen and a predetermined use (0040).
With respect to with respect to the third recited step of claim 1, Herickhoff (‘809) teaches providing a holding media that is adapted (created) to prevent anticipated cell damage. Herickhoff (‘809) teaches that holding media can be a diluent or a solution used for cells stored at a cooled temperature or a culture media (is not a cryopreservation) (0010-0011, 0041 and 0047). Herickhoff (‘809) teaches the holding media can further contain antibiotics (antimicrobial agent) (0023). The storage location of cells is a treatment location which is different from the harvesting location. The cells would inherently have to be transported from the place they were harvested to the treatment location in the method of Herickhoff (‘809). For instance, Herickhoff (‘809) teaches collecting sperm from stallions, diluting semen samples in a medium and then refreezing the dilution (0050-0051).
With respect to with respect to the fourth recited step of claim 1, Herickhoff (‘809) teaches adding the medium to the cells before freezing the cells which would require transporting the cells after diluting to the freezing location, and, therefore, the creation of a biological cell transport preservation composition (0010-0011, 0041 and 0047).
Although, Herickhoff (‘809) does not explicitly teach the sixth recited step of claim 1 of transporting the cells in the biological cell transport preservation composition from the cell harvesting location to treatment location, the seventh recited step of claim 1 of preventing damage to the biological cells during transporting, and the tenth recited step of claim 1 of receiving the cells in the biological cell transport preservation composition after transporting the cells, these steps are commonly performed and well-known in the art and would have been obvious at the effective time of filing of the claimed invention. The shipping and/or transporting and receipt of cells is well-known in the art as taught by Palecek. Palecek teaches a method of protecting cells and where the method is used to protect the cells during shipping and handling of embryonic stem cells (abstract, 0024 and 0042). Additionally, the claimed steps of transporting and receiving the biological cells in the holding medium includes the act of moving of the biological cells from one room to another or from one bench to another within the same room. Furthermore, one of ordinary skill in the art would have a reasonable expectation of success in modifying the method of Herickhoff (‘809) to include the steps of transporting and receiving the biological cells in the holding medium, since these were well-known steps included in methods of protecting cells as taught by Palecek.
With respect to with respect to the ninth recited step of claim 1, Herickhoff (‘809) teaches the method where the holding medium contains antibiotics and would therefore provide reduced bacterial growth, increase bacteriostatic effect and increased bactericidal effects (0023 and 0048). With respect to with respect to the eleventh and twelfth recited steps of claim 1, Herickhoff (‘809) teaches hypothermically treating the biological cells (0011 and 0051). With respect to with respect to the thirteenth recited step of claim 1, Herickhoff (‘809) teaches warming the cells (0013 and 0048). With respect to with respect to the fourteenth recited step of claim 1, Herickhoff (‘809) teaches using the cells (0014 and 0066-0071).
Herickhoff (‘809) does not teach the method where the holding media contains a phospholipase inhibitor or the step of inhibiting phospholipase in the biological cells with inhibitor during the step of transport as recited in the third recited and eighth recited step of claim 1, respectively. However, Kravitz teaches a similar method of preserving in vitro biological cells in a holding media where exemplary biochemical and pharmacological additives for preservation media include phospholipase inhibitors (0001 and Table 3). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Herickhoff (‘809) to include a phospholipase inhibitor for its known benefit in preserving biological cells as taught by Kravitz. One of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of Herickhoff (‘809) at the effective time of filing of the claimed invention to include a phospholipase inhibitor in the holding media which is used during transporting the cells to the cooling facility, since similar methods of protecting biological cells include a phospholipase inhibitor in the holding medium as taught by Kravitz. It would have been obvious to would have been obvious to one of ordinary skill in the art to modify the method of Herickhoff (‘809) to include a phospholipase inhibitor in the holding media for these same reasons.
Herickhoff (‘809) does not explicitly teach creating a uniform environment around the biological cells in the holding media by adding fatty acids to the biological cells in the holding media to create a biological cell transport preservation composition as recited in the fifth recited step of claim 1. Similarly, Herickhoff (‘809) does not teach the method where the step of adding fatty acids to the biological cells involves adding about 0.5 to about 10% v/v of fatty acids to the see the cells as recited in claim 78. Additionally, Herickhoff (‘809) does not teach the method where the step of adding fatty acids to the biological cells involves adding about 40% linolenic acid (18:3), about 15% linoleic (18:2) and about 20% palmitic to the collection of biological cells as recited in claims 79 and 80.
However, Licari teaches a method of protecting biological cells where preservation medium (holding medium) is provided and which contains the fatty acids, linoleic acid, linolenic acid, and palmitic acid (abstract, 0001, 0013, 0040, and 0095-0097). Licari teaches the preservation medium contains no animal origin components so that it can be used therapeutic products (0102). Although Licari does not teach the method where adding the fatty acids results in creating the uniform environment around the cells as recited in claim 1, this appears to be inherent to adding fatty acids to the media. Specification states that creating an uniform environment around the biological cells comprises the step of adding fatty acids to the cells (see published application 00186). Thus, the claimed result of creating an uniform environment around the biological cells must be inherent to the method as taught by Licari and a necessary effect of practicing the method.
With respect to claims 78-80, Licari teaches adapting the preservation medium according to the application envisage and adjust the amount of the components (0104-0160) and the fatty acids can include linoleic acid, linolenic acid and palmitic acid (0095-0097). Licari does not explicitly teach the method where the step of adding lipids involves adding about 0.5 to about 10% v/v of fatty acids to the see the cells as recited in claim 78 or involves adding about 40% linolenic acid (18:3), about 15% linoleic (18:2) and about 20% palmitic to the collection of biological cells as recited in claims 79 and 80. Although Licari does not teach the ranges as recited in claims 78-80, one of ordinary skill in the art would recognize that the concentrations of fatty acids is a result effective variable and that the amount would be matter of routine optimization as taught by Licari.
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Herickhoff (‘809) to include fatty acids in the holding media for their known benefits in preserving biological cells and allowing for a medium that does not contain animal components as taught by Licari. One of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of Herickhoff (‘809) at the effective time of filing of the claimed invention to include the fatty acids, linoleic acid, linolenic acid and palmitic acid, in the holding media, since similar methods of protecting biological cells include linoleic acid, linolenic acid and palmitic acid in the holding medium as taught by Licari. It would have been obvious to would have been obvious to one of ordinary skill in the art to modify the method of Herickhoff (‘809) to include free fatty acids and the fatty acids, linoleic acid, linolenic acid and palmitic acid, in the holding media for these same reasons.
With respect to claim 2, Herickhoff (‘809) teaches the method where the biological cells are reproductive cells including oocytes, sperm cells, embryos, embryonic stem cells, cell lines (artificially derived cells), and bovine, equine, ovine, porcine or avian sperm (0008 and 0022). With respect to claim 3, Herickhoff (‘809) teaches the cell source can be bovine, equine, ovine, porcine or avian (0011 and 0044). With respect to claim 4, Herickhoff (‘809) teaches the cells for use in insemination, implantation, cryopreservation, culturing, research, gamete preservation, and diagnostic testing (0023, 0027, 0039 and Examples) . Additionally, based on the disclosure of Herickhoff (‘809) it would have been within the purview of one of ordinary skill in the art to recognize that the preserved cells could be used for replication, genetic preservation and reproduction, since Herickhoff (‘809) teaches the storing of gametes and cells from different tissues and tests the cells for viability (see entire document).
With respect to claim 5, Herickhoff (‘809) teaches the holding media further containing antibiotics (bactericidal compound), buffer, antioxidant, cholesterol, lecithin, milk (contains carbohydrates, lipid, sugar, salt, and proteins as evidenced by Guetouache), sugar, albumin and casein (proteins), compound molecules, plant extract, and extract from plants of Sea Buckthorn (contains phytochemicals and secondary metabolites of plants) (0008 and 0023). Guetouache reports that milk contains carbohydrates, lipid, salt, protein, and lactose (sugar) (abstract and pg. 116 Col. 1 para. 7). With respect to claim 7, Herickhoff (‘809) teaches the method where the holding media contains a plant extract that is an alcohol extract of fruit or leaf, juice, hydroglycerin extract, and a combination of extracts (more than one source) (0061 and 0063). With respect to claim 13, Herickhoff (‘809) teaches the method where the holding container contains extracts as a liquid coating which are release when contacted with the liquid media which would provide time release of the extract compounds (0078).
With respect to claim 15, Herickhoff (‘809) teaches the method further comprising the step of adding a cryoprotectant to the biological cells where cryopreservation fluid contains glycerol, dimethylsulfoxide, or ethylene glycol (0023, 0048, 0050-0051, 0075). With respect to claim 17, Herickhoff (‘809) teaches a step of cooling the cells in the composition or medium (0011 and 0051). Although, Herickhoff (‘809) does not explicitly teach the step of adding a cryoprotectant to the biological cells happens after the step of receiving and transporting the cells in the holding medium or the step of cooling occurs during transporting the biological cells in the holding media; it would have been obvious to one of ordinary skill in the art to perform these steps during these additional steps. These steps are commonly performed and well-known in the art and would have been obvious at the effective time of filing of the claimed invention. The shipping and/or transporting and receipt of cells is well-known in the art as taught by Palecek. Palecek teaches a method of protecting cells and where the method is used to protect the cells during shipping and handling of embryonic stem cells (abstract, 0024 and 0042). Additionally, the claimed steps of transporting and receiving the biological cells in the holding medium includes the act of moving of the biological cells from one room to another or from one bench to another within the same room. Furthermore, one of ordinary skill in the art would have a reasonable expectation of success in modifying the method of Herickhoff to include the steps of transporting and receiving the biological cells in the holding medium, since these were well-known steps included in methods of protecting cells as taught by Palecek.
With respect to claim 26, Herickhoff (‘809) teaches the method where the holding medium or biological cell transport preservation composition contains antibiotics and would therefore provide reduced bacterial growth, increase bacteriostatic effect and increased bactericidal effects (0023 and 0048). With respect to claim 30, Herickhoff (‘809) teaches the method where the holding medium contains antibiotics and plant extracts (0008, 0015-0016, 0023, and 0048). Herickhoff further teaches the plant oil extract from Sea Buckhorn has bactericidal effects (0003). With respect to claim 35, Herickhoff (‘809) teaches the method where bacterial contamination is reduced (0023 and 0048). With respect to claim 38, Herickhoff (‘809) teaches preparing the cells before freezing by mixing the cells with the cryopreservation fluid or holding media and then cooling or freezing the cells (0048, 0050-0051, and 0061-0062).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 8, 10, and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Herickhoff (‘809) in view of Palecek, Kravitz, and Licari (as applied to claim 1 above), and further in view of Herickhoff et al. (US 2015/0037783 A1) (ref. of record) (“Herickhoff (‘783)”).
The teachings of Herickhoff (‘809), Palecek and Kravitz can be found in the previous rejection above.
Herickhoff (‘809) does not teach the method where the holding media contains one of the antimicrobial agents listed in claim 8. However, Herickhoff (‘783) teaches a similar method of protecting biological cells in vitro by preserving the cells in a cryopreservation fluid (holding medium) (0001) and the method where holding media contains triterpenes, tocopherol, carotenoids, phenolics, resveratrol (polyphenol), flavonoids, and terpenes (antimicrobial agents) (0035 and 0051-0053). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Herickhoff (‘809) to include one or more of the listed antimicrobial agents of claim 8 for their known benefit in preserving biological cells as taught by Herickhoff (‘783). One of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of Herickhoff (‘809) at the effective time of filing of the claimed invention to include one or more of the listed antimicrobial agents of claim 8 in the holding media, since similar methods of protecting biological cells include one or more of the listed antimicrobial agents of claim 8 in the holding medium as taught by Herickhoff (‘783). It would have been obvious to would have been obvious to one of ordinary skill in the art to modify the method of Herickhoff (‘809) to include one or more of the listed antimicrobial agents of claim 8 in the holding media for these same reasons.
Neither, Herickhoff (‘809) or Kravitz teach the method where the phospholipase inhibitor is one of those listed in claim 10. However, Herickhoff (‘783) teaches a similar method of protecting biological cells in vitro by preserving the cells in a cryopreservation fluid (holding medium) (0001) and the method where one embodiment of the cryopreservation fluid contains citric acid (phospholipase inhibitor) (0041). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Herickhoff (‘809) to include citric acid for its known benefit in preserving biological cells as taught by Herickhoff (‘783). One of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of Herickhoff (‘809) at the effective time of filing of the claimed invention to include citric acid in the holding media, since similar methods of protecting biological cells include citric acid in the holding medium as taught by Herickhoff (‘783). It would have been obvious to would have been obvious to one of ordinary skill in the art to modify the method of Herickhoff (‘809) to include citric acid in the holding media for these same reasons.
Herickhoff (‘809) does not teach the method where the step of cooling the cells is at a rate of 0.01°C/min to about 1°C/min as recited in claim 19. However, Herickhoff (‘783) teaches a similar method of preserving cells and teaches cooling at a rate of -1°C/min to -3°C/min as a general rule of thumb and that it is understood that the rate of cooling varies by cell and tissue type (0001 and 0003). Although Herickhoff (‘783) does not teach the exact range of cooling the cells is at a rate of 0.01°C/min to about 1°C/min as recited in claim 19, the ranges overlap significantly with the ranges taught. Furthermore, one of ordinary skill in the art would recognize that the cooling rate of the biological cells is a result effective variable and that the cooling rate of the biological cells would be matter of routine optimization as evidence by Herickhoff (‘783). Herickhoff (‘783) teaches cooling at a rate of -1°C/min to -3°C/min as a general rule of thumb and that it is understood that the rate of cooling varies by cell and tissue type (0003). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Herickhoff (‘809) to cool the cells at a known cooling rate of 0.01°C/min to about 1°C/min for the benefit of cryopreserving the cells as taught by Herickhoff (‘783). It would have been obvious to one of ordinary skill in the art to use known cooling rates of cells in the art and to adjust the rate according to the cell and tissue type as taught by Herickhoff (‘783). Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of Herickhoff (‘809) to cool the cells at a cooling rate of 0.01°C/min to about 1°C/min, since Herickhoff (‘783) teaches a overlapping range of cooling rate for the cryopreservation of cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed Sept. 25, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that Herickhoff ‘809 does not teach the new limitation of creating an uniform environment around the cells by adding fatty acids to the collection biological cells (Remarks pg. 7 last para.). Applicant further argues that Herickhoff ‘783 teaches a cryopreservation media which is different from the claimed holding media for transporting cells and there is no teaching in Herickhoff ‘783 for the use of fatty acids in a holding medium that is not a cryopreservation medium (Remarks pg. 7-8 bridging para.). Applicant argues that Herickhoff ‘783 is solving a different problem than the claimed invention with different physiological stresses. Specifically, Applicant argues that Herickhoff ‘783 addresses the improving of post-thaw viability by manipulating lipid droplet size and surface energy for cryopreservation whereas claim addresses the problem of preventing cell damage during transportation and a predetermined use before treatment (Remarks pg. 8 para. 2). Applicant argues that Herickhoff ‘783 does not teach the applicability of fatty acids in non-cryogenic holding media and instead teaches that adding lipids to cell culture media can be toxic and detrimental to the cells and that the use of lipids in the cryopreservation media is very specific. Applicant further argues that a person of ordinary skill in the art would not reasonably extend the cryopreservation solution of Herickhoff ‘783 to a non-cryogenic transport medium (Remarks pg. 8 para. 3). Applicant argues that Herickhoff ‘783 does not disclose that the lipid-modified cryopreservation media is equivalent to a transport holding medium or where the lipids can be used in a non-frozen, non-cryogenic media for temporary storage or transportation (Remark pg. 8 para. 4). The Applicant’s amendments limiting claim 1 to include this new limitation of the holding medium requiring fatty acids necessitated a new rejection. Applicant’s arguments are drawn to Herickhoff ‘783 failing to teach this new limitation. However, this new limitation is addressed in the new rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632