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 .
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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 1, 2026 has been entered. All arguments and the IDSs submitted on May 1, 2026 and Sept. 25, 2025 have been fully considered.
Status of the Claims
Claims 1-5, 7, 8, 10, 13, 15, 17, 19, 26, 30, 35, 38, and 78-79 are currently pending.
Claims 1-3, 15, 19, 26, 30, 38, 78 and 79 are amended.
Claims 6, 9, 11, 12, 14, 16, 18, 20-25, 27-29, 31-34, 36, 37, 39-44, 48-62, 64-77 and 80 are cancelled.
Claims 1-5, 7, 8, 10, 13, 15, 17, 19, 26, 30, 35, 38, and 78-79 have been considered on the merits.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment.
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The claim rejections under 35 USC § 103 are withdrawn due to amendment.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 78-79 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), Tarig et al. (Animal Reproduction Science, 2017) and Licari et al. (US 2007/0087320 A1) (ref. of record).
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). Further with respect to claim 1, Herickhoff teaches the cells being preserved are sperm cells (0013 and 0022).
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 sperm 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 sperm 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 sperm 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 sperm 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 claim 79.
However, Tarig teaches that egg yolk is used to protect the plasma membrane integrity of sperm during the freezing process, because of the presence of phospholipids in the association with other components (pg. 22 para. 1). In addition, Tarig reports that linoleic acid, palmitic acid and alpha-linolenic acid have been used successfully for sustaining general sperm motility viability and membrane integrity in chilled and cryopreserved semen of boars and bulls (pg. 22 para. 1). Tarig states that “lipids are essential to increase the fluidity of sperm membrane and prevent sperm impairment caused by ice crystals throughout the freezing process and increase fertilizing capability of the sperm (pg. 25 para. 2). Tarig further teaches that “motility and viability of chilled bull sperm after 7 days were reported to be improved by the addition of oleic acids (10 and 100 µM), palmitic acid (100 µM) and ALA (10 and 100 µM) in citrate based extenders with and without egg yolk (pg. 25 para. 2).
In addition, 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).
Neither Tarig nor Licari teach the method where adding the fatty acids results in creating the uniform environment around the sperm cells as recited in claim 1. Similarly, neither Tarig nor Licari teach the uniform environment around each of said sperm cells comprises forming a lipid layer around a sperm cell membrane of each of said sperm cells as recited in claim 1. However, these appear 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) and there is no explicit description of how the lipid layer is formed (0089, 0182 and 0262). Thus, the claimed result of creating an uniform environment where a lipid layer is formed around the sperm cells must be inherent to the method as taught by the combined teachings of Herickhoff (‘809), Tarig and Licari and a necessary effect of practicing the method.
Tarig 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 claim 79. However, 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). Although, neither Tarig nor 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 maintaining the integrity of sperm cell membranes and viability and for preserving biological cells and allowing for a medium that does not contain animal components as taught by Tarig and 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 and sperm cells include linoleic acid, linolenic acid and palmitic acid in the holding medium as taught by Tarig and 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 sperm cells and teaches 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, Tarig, 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, Tarig 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 May 1, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that Licari does not teach the new limitation of creating an uniform environment by forming a lipid layer around the cell membranes of sperm and only teaches a preservation medium for organs, tissues and cells where the components that interact and surround the cells and tissues are high-molecular-weight polymers and not lipids (Remarks pg. 8-9 bridging para.). The Applicant’s amendments limiting claim 1 to include the new limitations of sperm cells and where the lipid layer forms around the sperm cells necessitated a new rejection. Applicant’s arguments are drawn in part to Licari failing to teach these new limitations. However, the new limitations are addressed in the new rejection. Additionally, it is maintained that the addition of fatty acids to the medium would inherently result in the claimed creating of an uniform environment around each of the sperm cells by forming a lipid layer around a sperm cell membrane. In support, Tarig reports that linoleic acid, palmitic acid and alpha-linolenic acid sustain membrane integrity in both chilled and cryopreserved semen (pg. 22 para. 1).
Applicant argues that this limitation of adding fatty acids to create an uniform environment around cells is not inherent to Licari, since Licari does not teach that fatty acids associate with membranes in a structured way or form any layer around cells (Remarks pg. 9 para. 2). However, this argument was not found to be persuasive, since the combined teachings of Tarig and Licari teach the method of adding fatty acids to the medium of the sperm cells or biological cells.
Neither, Tarig and Licari explicitly teach that the addition of fatty acids can be used in the manner instantly claimed for creating a uniform environment by forming a lipid layer around a sperm membrane as recited in claim 1. However, the combined teachings of Tarig and Licari teach the claimed method of adding a fatty acid to a preservation medium for sperm. Once the fatty acids are added they should result in a lipid bilayer. In support, the 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 uniform environment by forming a lipid layer around a sperm membrane must be inherent to the method as taught by the references and a necessary effect of practicing the method.
Specifically, Applicant argues that the sperm have highly specialized membrane properties that are not addressed in Licari, since Licari is primarily concerned with human corneal endothelial cells and other tissues that are different from spermatozoa and the interactions between lipids and sperm membranes are highly specific, tightly regulated and not representative of general cell behavior (Remarks pg. 9 para. 3). The Applicant’s amendments limiting claim 1 to include the new limitations of sperm cells and where the lipid layer forms around the sperm cells necessitated a new rejection. Applicant’s arguments are drawn in part to Licari failing to teach these new limitations. However, the new limitations are addressed in the new rejection.
Applicant argues Licari does not teach claimed amounts of lipids recited in claims 78 and 79, and these amounts are not arbitrary since the amounts influence lipid packing, fluidity, and interfacial organization which governs whether the lipids remain dispersed, form micelles or associated with membranes (Remarks pg. 9 para. 4). Applicant further argues that there is no basis for routine optimization to arrive at the claimed composition or the resulting lipid-associated layer, since Licari attributes the cell-surrounding or protective effects of the medium to the viscoelastic polymers and not to lipids, the mere presence of fatty acids in a complex aqueous medium does not inherently result in the formation of a lipid associated layer around each cell membrane, and fatty acids exhibit variable behavior depending on concentration and environment (Remarks pg. 9 last para.). However, these arguments were not found to be persuasive, since Licari teaches that the components of preservation media which would include fatty acids are adjusted according to the application. It is maintained that the amount of fatty acids would be adjusted as a matter of routine optimization depending on the situation. Additionally, it is maintained that the addition of fatty acids to the medium would inherently result in the claimed creating of an uniform environment around each of the sperm cells by forming a lipid layer around a sperm cell membrane. In support, Tarig reports that linoleic acid, palmitic acid and alpha-linolenic acid sustain membrane integrity in both chilled and cryopreserved semen (pg. 22 para. 1). In addition, the 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) which is taught by Tarig and Licari.
Applicant argues that there is no basis to conclude that Licari’s disclosure would result in the formation of a lipid-associated layer around sperm cell membranes, since Licari does not teach sperm cells Remarks pg. 9-10 bridging para.). As stated previously, Applicant’s amendments limiting claim 1 to include the new limitations of sperm cells and where the lipid layer forms around the sperm cells necessitated a new rejection. Applicant’s arguments are drawn in part to Licari failing to teach these new limitations. However, the new limitations are addressed in the new rejection. Additionally, it is maintained that the addition of fatty acids to the medium would inherently result in the claimed creating of an uniform environment around each of the sperm cells by forming a lipid layer around a sperm cell membrane. In support, Tarig reports that linoleic acid, palmitic acid and alpha-linolenic acid sustain membrane integrity in both chilled and cryopreserved semen (pg. 22 para. 1).
Conclusion
No claims are allowed.
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
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