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
Applicant’s submission filed on February 11, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed November 13, 2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 has been amended to recite limitations of claim 9 “wherein a temperature of the first side is higher than a temperature of the second side” and limitations of “the porous later is configured to delay a thermal equilibrium between the first side and second side”. Claim 9 has been amended to remove language in accordance with amended claim 1.
Claims 1-10 are pending and examined on the merits.
Priority
The instant application is a continuation-in-part of U.S. Application 17/835626 filed on June 8, 2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 10, 2024 and February 11, 2026 are in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Withdrawn Claim Objections
In light of Applicant’s amendment to claim 1 according to suggestions from the office, the objection to claim 1 has been withdrawn.
Terminal Disclaimer
The terminal disclaimed to provisional application 17/835,626 filed on February 11, 2026 have been acknowledged and overcome the provisional double patenting rejection.
Claim Rejections - 35 USC § 103
This is a new rejection necessitated by Applicant’s amendment. However, this rejection shares substantial similarity to the rejection as previously set forth in the office action dated November 13, 2025. Any aspect of Applicant’s traversal that pertains to the rejection as newly set forth will be provided following the new statement of rejection.
Claims 1-3, 6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vollmer (US 2018/0282676 A1) in view of Perez-Cerezales et al. (2018, Sperm selection by thermotaxis improves ICSI outcome in mice. Scientific Reports, 8(1), 2902, hereafter “Perez-Cerezales”) and as evidenced by Huang et al. (2018, Thermal conductivity of polymers and polymer nanocomposites. Mat. Sci. and Engin.: R: Reports, 132, 1-22, hereafter “Huang”).
With regard to claim 1, Vollmer discloses a method for separation of a biological sample, preferably semen, into a first and second portion based on motility-based separation of biologically active sperm (Para. [0001]). Vollmer’s method discloses use of a device comprising a first layer comprising a first reservoir which receives the sperm sample and retains the first portion of the sample and a second layer comprising a second reservoir for receiving the second portion of the sample (Para. [0010], lines 3-6), wherein a separation layer is present between the first and second layers (Para. [0010, lines 12-13), and wherein the separation layer comprises a porous structure and is configured to selectively separate the sperm sample between the first and second layers/reservoirs into a first sample portion and second sample portion (Para. [0011], lines 1-5, see also Figs. 1A-1B). The first layer/reservoir disclosed by Vollmer which receives the initial sperm sample is considered to reasonably read on the instantly claimed “second side” and the second layer/reservoir as disclosed by Vollmer which retains the separated sperm sample is considered to reasonably read on the instantly claimed “first side”. Vollmer discloses that sperm cells can be separated from the second side into the first side (Para. [0035], lines 5-7) and subsequently removed from the first side (Para. [0040], lines 3-4). Additionally, Vollmer discloses that separation of sperm cells occurs due to “biological activity, preferably motility, and/or gravitational force” (Para. [0060], lines 1-3) and can be facilitated using a temperature gradient (Para. [0065], lines 1-4). Further, Vollmer discloses that highly motile sperm with accumulate at the first side whereas non-motile sperm accumulate at the second side (Para. [0060], lines 5-8), which is considered to reasonably read on generation of a sorted sperm sample at the first side as a result of the method.
Vollmer teaches that the porous layer between the first and second sides is configured to minimize the occurrence of convection (Para. [0031], lines 8-9), which is considered to reasonably read on a porous layer which is configured to delay a thermal equilibrium. Further, Vollmer teaches that the porous layer can be a polymer-based membrane (Para. [0030]) and Huang evidences that polymers are poor thermal conductors (Abstract) which a skilled artisan would recognize would delay thermal equilibrium. Therefore, the porous membrane as taught by Vollmer is considered to read on a porous layer capable of delaying thermal equilibrium.
While Vollmer provides support for use of temperature gradients for sorting sperm, Vollmer does not specifically teach a temperature gradient formed between the first side and second side.
Perez-Cerezales teaches a method of sperm selection using thermotaxis wherein thermotaxis can be used to select high-quality sperm which generate better embryos (Abstract). Perez-Cerezales teaches that the use of swim-up techniques which are able to recover at least a portion of “higher quality” sperm (Pg. 1, 2nd Para.) and that thermotaxis can be used in order to improve sperm selection (Pg. 2, 3rd para.). Perez-Cerezales teaches use of “separation unit” wherein a temperature gradient was maintained between the loading side (i.e., the second side) and the retrieving side (i.e., the first side) of the separation unit, wherein the temperature was higher on the retrieving side (i.e., the first side) (Results, Sperm thermotaxis in mice and humans and Fig 1.). Perez-Cerezales teaches use of a temperature control unit (Supplementary Fig 1) to maintain the temperature gradient and that the temperature gradient enabled separation of a greater number of sperm (Fig. 1) which were also of high quality (Fig. 3).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to apply use of a temperature gradient between a first and second side to separate high quality sperm as taught by Perez-Cerezales to Vollmer’s method of separating sperm by gravitational force using a device comprising a first side which receives a sperm sample and second side which retains the separated sperm sample, wherein the first and second sides are separated by a porous layer configured to delay a thermal equilibrium with a reasonable expectation of success. As Vollmer teaches that temperature gradients can be used in addition to Vollmer’s separation device in order to effectively separate sperm and Perez-Cerezales teaches that a temperature gradient between a first and second side was able to separate more sperm which was of higher quality, a skilled artisan would have recognized that use of a temperature gradient in addition to Vollmer’s separation method would help isolate better quality sperm which is important in the field of assistive reproductive technology.
With regard to claim 2, Vollmer discloses that the sorting device comprising layers which is used in the method are stackable “in a substantially vertical plane” (Para. [0010], lines 17-18), which reasonably reads on the step of vertical alignment of the first and second sides.
With regard to claim 3, as detailed above, Vollmer discloses a method of separating sperm via use of a sperm sorting device comprising first and second reservoirs in a vertical orientation wherein the second reservoir, which is considered to reasonably read on the instantly disclosed “upper chamber”, is adjacent to and in communication with the porous layer (Figs. 1A-1B) and wherein the upper chamber comprises a fluidic buffer (Para. [0034], lines 1-3) which reasonably reads on the step of disposing buffer in the upper chamber.
With regard to claim 6, as detailed above, Vollmer discloses a method of separating sperm via use of a sperm sorting device comprising first and second reservoirs in a vertical orientation wherein the first reservoir, which is considered to reasonably read on the instantly disclosed “lower chamber”, is adjacent to and in communication with the porous layer (Figs. 1A-1B) and wherein the first reservoir receives the sperm sample (Para. [0010], lines 3-4), which reasonably reads on the step of disposing unsorted sperm in the lower chamber.
With regard to claim 9, as detailed above combination of Vollmer and Perez-Cerezales teaches a method of separating sperm via use of a device comprising an upper and lower chamber separated by a porous layer where a sperm sample is disposed in the lower chamber and is separated into the upper chamber using a temperature gradient and gravitational force prior to being retrieved as a separated sperm sample comprising highly-motile sperm from the upper chamber. The combination of Vollmer and Perez-Cerezales teaches that the temperature is higher on the first side (the upper chamber) than the second side (the lower chamber).
Regarding generation of the temperature gradient, Perez-Cerezales teaches use of a temperature gradient from 35°C on the sample loading side (i.e., the second side) to 38°C on the sample collection side (i.e., the first side) which resulted in higher number of sperm accumulated on the collection side when compared to control conditions (Results, Sperm thermotaxis in mice and humans; Fig 1a & 1b).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine separation of highly motile sperm from non-motile sperm via temperature gradient as taught by Vollmer with the specific temperature gradient of 35°C on the sample loading side (i.e., the instantly claimed second side) to 38°C on the sample collection side (i.e., the instantly claimed first side) which is effective for separation of high quality sperm as taught by Perez-Cerezales. As Vollmer teaches use of temperature gradients in separation of sperm samples and Perez-Cerezales teaches that the particular temperature gradient of 35-38° C is effective for separating high-quality sperm, a skilled artisan could have applied the specific temperature gradient as taught by Perez-Cerezales to the method of separating sperm samples as taught by Vollmer with the predictable result of generating a separated sperm sample comprising highly-quality sperm. One having ordinary skill it the art would have had a reasonable expectation of success as both Vollmer and Perez-Cerezales teach separation of sperm using temperature gradients.
With regard to claim 10, Vollmer discloses a time period of 10-60 minutes and a preferred embodiment of 30 minutes for separation of the initial sperm sample prior to collection (Para. [0064], lines 3-5).
Claims 4-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vollmer in view of Perez-Cerezales and as evidenced by Huang as applied to claims 1-3 and 6 above, and further in view of Wei (CN 107099444A, found in IDS, Espacenet translation attached for clarity).
With regard to claims 4-5, as detailed above, the combination of Vollmer and Perez-Cerezales teach a method of separating sperm via use of a device comprising an upper and lower chamber separated by a porous layer wherein a sperm sample is disposed in the lower chamber and is separated into the upper chamber via a temperature gradient, wherein the temperature on the first side is higher than the temperature on the second side and the porous layer is configured to delay thermal equilibrium, and by gravitational force prior to being retrieved as a separated sperm sample comprising highly-motile sperm from the upper chamber.
While Vollmer teaches that the system comprises heating unit (Para. [0053], line 1), and the combination of Vollmer and Perez-Cerezales make obvious use of a heating unit to generate a temperature gradient, the combination of Vollmer and Perez-Cerezales does not teach wherein the temperature gradient is formed by heating the upper chamber through a temperature controlling component nor does Vollmer teach providing a temperature difference device formed with a sorting device accommodating portion, wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the upper chamber, and the sorting device accommodating portion is adapted to accommodate at least a portion of the sperm sorting device.
Wei teaches a sperm detection method using a sperm sorting chip wherein the sperm sorting chip comprises a series of plates and a temperature control module and wherein the upper plate has an injection hole for disposing a sperm sample and a “suction hole” for collecting the sorted sperm sample and that the two holes are connected by a sorting groove. Wei teaches that by activating the temperature control module, a temperature gradient is formed such that the temperature of the injection hole is lower than that of the suction hole in order to induce the sperm to move toward the suction hole (Para. [0021], see also Fig 1). Wei teaches that in order to sort the sperm sample, the sperm sorting chip is placed vertically with the injection hole at the bottom and the suction hole at the top (this is considered to reasonably read on a lower chamber where the sperm sample is initially disposed and an upper chamber where the sorted sperm sample is collected), and the temperature control module generates a temperature gradient wherein the temperature at the injection hole/lower chamber is lower than the temperature at the suction hole/upper chamber which causes the sperm to “overcome gravity” and swim toward the higher temperature (Para. [0022]). Additionally, Wei teaches that the temperature control module includes a heat-conducting sheet and a heating module for heating the sheet (Para. [0029]) wherein the heating module is located at the end of the sperm sorting plate corresponding to the suction hole, i.e. the upper chamber (Para. [0030]). This is considered to reasonably read on forming the temperature difference by heating the upper chamber through a temperature controlling component.
Further, Wei teaches a sperm detection device comprising a device body having an inner cavity (Para. [0025]) wherein the device body comprises a slot for placing the sperm sorting chip (Para. [0036]) and the sperm sorting chip is disposed in the inner cavity such that the injection hole is located below the suction hole (Para. [0026]). The device comprises a temperature control module comprising a heat-conducting sheet which is attached to the sperm sorting chip and fixedly mounted to the inner wall of the device cavity (Paras [0029] and [0030]; See also Fig 4 and Paras. [0087] and [0088]). This is considered to reasonably read on a temperature difference device comprising an accommodating portion for a sorting device wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the upper chamber and wherein the sorting device accommodating portion is adapted to accommodate a portion of the sperm sorting device.
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine the method of sorting a sperm sample using a temperature gradient and a porous membrane as taught by combination of Vollmer and Perez-Cerezales with the method of sorting sperm comprising generating a temperature difference by heating the upper chamber using a temperature controlling component within a device body wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the upper chamber and the sperm sorting device can be accommodated by the device as taught by Wei. The combination of Vollmer and Perez-Cerezales teaches that high-motility sperm can be sorted via use of porous membranes in addition to temperature gradients and gravitational forces. Wei teaches that their sperm sorting device is able to sort sperm without DNA damage and using a chip comprising a simple structure and low cost (Para. [0023]) while also providing the added benefit of allowing subsequent testing of sorted sperm in the same device thus reducing the cost of additional testing of sorted sperm (Para. [0024]). Thus, a skilled artisan would have been motivated to combine the method of sperm sorting using a porous membrane and a temperature gradient and gravitational forces as taught by the combination of Vollmer and Perez-Cerezales with Wei’s device wherein sperm is first sorted by temperature gradient and gravitational forces but can be subsequently analyzed for additional metrics of sperm quality in order to reduce cost and processing time for sperm sorting which could lead to quicker and less costly sperm analysis for infertility treatments. A skilled artisan would have had a reasonable expectation of success as both Vollmer and Wei teach sorting of sperm using temperature gradients and gravitational forces.
With regard to claims 7-8, as detailed above, combination of Vollmer and Perez-Cerezales teach a method of separating sperm via use of a device comprising an upper and lower chamber separated by a porous layer wherein a sperm sample is disposed in the lower chamber and is separated into the upper chamber via a temperature gradient, wherein the temperature on the first side is higher than the temperature on the second side and the porous layer is configured to delay thermal equilibrium, and gravitational force prior to being retrieved as a separated sperm sample comprising highly-motile sperm from the upper chamber.
The combination of Vollmer and Perez-Cerezales does not teach wherein the step of forming the temperature difference between the first side and the second side comprises dissipating heat from the lower chamber through a temperature controlling component nor does Vollmer teach providing a temperature difference device formed with a sorting device accommodating portion, wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the lower chamber, and the sorting device accommodating portion is adapted to accommodate at least a portion of the sperm sorting device.
Wei teaches a sperm detection method using a sperm sorting chip wherein the sperm sorting chip comprises a series of plates and a temperature control module and wherein the upper plate has an injection hole for disposing a sperm sample and a “suction hole” for collecting the sperm sample and wherein the two holes are connected by a sorting groove. Wei teaches wherein by activating the temperature control module, a temperature gradient is formed such that the temperature of the injection hole is lower than that of the suction hole in order to induce the sperm to move toward the suction hole (Para. [0021], see also Fig 1). Wei teaches that in order to sort the sperm sample, the sperm sorting chip is placed vertically with the injection hole at the bottom and the suction hole at the top (this is considered to reasonably read on a lower chamber wherein the sperm sample is disposed and an upper chamber wherein the sorted sperm sample is collected) and the temperature control module generates a temperature gradient wherein the temperature at the injection hole/lower chamber is lower than the temperature at the suction hole/upper chamber which causes the sperm to “overcome gravity” and swim toward the higher temperature (Para. [0022]). Additionally, Wei teaches that the temperature control module includes a heat-conducting sheet and a heat dissipation module for dissipating heat from the sheet (Para. [0029]) wherein the heat dissipation module is located at the end opposite from the upper chamber, i.e., the injection end or lower chamber, of the sperm sorting plate (Para. [0030]), which is considered to reasonably read on forming a temperature difference by dissipating heat from the lower chamber through a temperature controlling component.
Further, Wei teaches a sperm detection device comprising a device body having an inner cavity (Para. [0025]) wherein the device body comprises a slot for placing the sperm sorting chip (Para. [0036]) and the sperm sorting chip is disposed in the inner cavity such that the injection hole is located below the suction hole (Para. [0026]). The device body comprises a temperature control module comprising a heat-conducting sheet which is attached to the sperm sorting chip and fixedly mounted to the inner wall of the device cavity (Paras [0029] and [0030]; See also Fig 4 and Paras. [0087] and [0088]). This is considered to reasonably read on a temperature difference device comprising an accommodating portion for a sorting device wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the lower chamber and wherein the sorting device accommodating portion is adapted to accommodate a portion of the sperm sorting device.
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine the method of sorting a sperm sample using a temperature gradient and a porous membrane as taught by combination of Vollmer and Perez-Cerezales with the method of sorting sperm comprising generating a temperature difference by heating the upper chamber using a temperature controlling component within a device body wherein the temperature controlling component is disposed at the temperature difference device and adjacent to the upper chamber and the sperm sorting device can be accommodated by the device as taught by Wei. The combination of Vollmer and Perez-Cerezales teaches that high-motility sperm can be sorted via use of porous membranes in addition to temperature gradients and gravitational forces. Wei teaches that their sperm sorting device is able to sort sperm without DNA damage and using a chip comprising a simple structure and low cost (Para. [0023]) while also providing the added benefit of allowing subsequent testing of sorted sperm in the same device thus reducing the cost of additional testing of sorted sperm (Para. [0024]). Thus, a skilled artisan would have been motivated to combine the method of sperm sorting using a porous membrane and a temperature gradient and gravitational forces as taught by the combination of Vollmer and Perez-Cerezales with Wei’s device wherein sperm is first sorted by temperature gradient and gravitational forces but can be subsequently analyzed for additional metrics of sperm quality in order to reduce cost and processing time for sperm sorting which could lead to quicker and less costly sperm analysis for infertility treatments. A skilled artisan would have had a reasonable expectation of success as both Vollmer and Wei teach sorting of sperm using temperature gradients and gravitational forces.
Response to Arguments
Applicant's arguments filed February 11, 2026 have been fully considered but they are not persuasive.
First, Applicant traverses on Pg. 6 that neither Vollmer nor Perez-Cerezales disclose or suggest all the technical features recited in the amended claims. Applicant asserts on Pg. 7, that Vollmer’s method of sperm sorting uses the physical configuration of channels in a third layer and that Vollmer does not disclose establishment of a vertical temperature gradient or use of a porous layer as a thermal barrier and therefore Vollmer’s method of separation of sperm is different from the instantly claimed method. Applicant concedes on Pg. 8 that Vollmer discloses that temperature gradients may provide increased, enriched, or faster separation of highly motile sperm, but asserts that this suggestion of Vollmer is not sufficient to teach a skilled artisan to use a temperature gradient where the temperature of the first side is higher than the temperature of the second side and where a porous later is used to delay thermal equilibrium as instantly claimed.
Second, Applicant traverses on Pg. 9-10 that Perez-Cerezales’ temperature gradient of 35-38 °C only verifies thermotaxis of sperm horizontally but does not teach that the same process would happen vertically and that the horizontal capillary tube used by Perez-Cerezales could not be adapted to the vertical porous layer as taught by Vollmer. Therefore, Applicant asserts that the disclosure of Perez-Cerezales cannot be applied to Vollmer’s separation device/method and that based on the teachings of Vollmer and Perez-Cerezales a skilled artisan could not have foreseen the technical features of a porous layer used to delay thermal equilibrium between the first and second side and collection of sorted sperm based on temperature difference and overcoming gravity.
Third, Applicant traverses that Wei’s mechanism of sorting of sperm, which teaches vertical orientation of a sperm sorting chip (i.e., sperm sorting by overcoming gravity) in conjunction with generation of a temperature gradient via use of a temperature controlling component to heat the upper portion and a temperature dissipating component to cool the lower portion is different than the instantly claimed mechanism which uses a porous layer to delay thermal equilibrium (Pg. 12, 1st para.) and that without a thermal barrier element, Wei’s device would not generate a stable temperature gradient (Pg. 13, 1st para.). Applicant asserts that since Wei does not disclose a component which has thermal buffering ability, the combination of Vollmer, Perez-Cerezales, and Wei would not lead a skilled artisan to the instantly claimed method which employs a porous layer used to delay thermal equilibrium between the first side and second side and where the method results in sorted sperm based on a temperature difference and overcoming gravity.
Applicant's arguments have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
First, Applicant’s specification appears to admit that delaying of the thermal equilibrium is an inherent property of the porous layer (See Paras. [0038], [0044]) which could be performed by any porous layer. Second, Applicant has not claimed or disclosed the meaning or magnitude of “delay” as it relates to thermal equilibrium. One having ordinary skill in the art would recognize that the addition of any layer of any substance, including layers such as metal which have excellent thermal conductivity, would be expected to delay the thermal equilibrium by some amount. Third, Vollmer teaches a porous layer used in the method of sperm sorting via overcoming gravity is configured to minimize the occurrence of convection (Para. [0031]) and one of ordinary skill in the art would recognize that minimizing convection would delay thermal equilibrium. Fourth, Vollmer teaches that the porous layer can be polymer-based (Para. [0030]) and Huang evidences that polymers are known to have low thermal conductivity (Abstract). Therefore the use of a polymer-based porous layer as taught by Vollmer would result in a porous layer which is configured to delay thermal equilibrium as instantly claimed and would be readily envisioned by one having ordinary skill in the art.
Additionally, Vollmer teaches that temperature gradients could be used in addition to the vertical sperm sorting method to increase, enrich, or accelerate separation. The disclosure of Perez-Cerezales, which teaches that temperature gradients where the temperature on the depositing side is lower than the temperature on the retrieving side is effective for sorting high quality sperm, is relied upon for application of the temperature gradient without rigid application of the structural features. Because Vollmer suggests that application of a temperature gradient can be beneficial in a method of vertical sperm separation and Perez-Cerezales teaches that a temperature gradient is effective for sorting high quality sperm, one of ordinary skill in the art could readily envision application of the temperature gradient of Perez-Cerezales to the method of Vollmer to arrive at the instantly claimed method where a sperm sorting is based on a temperature gradient and overcoming gravity. Thus, in regard to Applicant’s arguments that the horizontal thermal system of Perez-Cerezales could not be successfully combined with the vertical sizing system of Vollmer, it has been held that the test for obviousness is not whether the features of one reference may be bodily incorporated into the other to produce the claimed subject matter but simply what the combination of references makes obvious to one of ordinary skill in the pertinent art. In re Bozek, 163 USPQ 545 (CCPA 1969). In instant case, it would have been predicably obvious to apply a thermal gradient across the vertical barrier of Vollmer (see modified Fig.7 of Vollmer below).
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With regard to Applicant’s traversal over the teachings of Wei, Vollmer teaches use of a porous membrane which is configured to minimize convection and that the porous membrane could be made from a polymer which generally have low thermal conductivity as evidenced by Huang. Therefore, the teachings of Wei are not relied upon for the application of a thermal buffering structure and a skilled artisan would have envisioned used of a porous layer which delays thermal equilibrium and sorting of sperm based on a temperature difference and overcoming gravity based on the combination of Vollmer and Perez-Cerezales.
Fourth, Applicant traverses that the instantly claimed technical effects could not have been predicted from the combination of Vollmer and Perez-Cerezales for a variety of reasons including that the open flow channels of Vollmer would result in rapid heat conduction and generation of convection (Pg. 10, 2nd para.), that the effect of maintaining a temperature difference over a small distance could not have been predicted by the combination of Vollmer and Perez-Cerezales (Pg. 10, 3rd para.), that rigid application of the temperature gradient over the distance as disclosed by Perez-Cerezales would result in a device having a large vertical distance (Pg. 11, 1st para.) and that the instantly claimed porous membrane is thinner than the one disclosed by Vollmer (Pg. 11, 2nd para). Applicant additionally asserts that the increase in values of VAP, VSL, an VCL in the method as instantly claimed could not have been predicted from the combination of Vollmer and Perez-Cerezales (Pg. 10, 3rd para.).
Applicant's arguments have been fully considered but they are not persuasive.
In regard to Applicant’s assertions that the structural features of Vollmer and Perez-Cerezales would not lead to generation of a stable temperature difference over a short distance. As detailed above, Vollmer teaches use of a porous membrane which is configured to minimize convection and that the porous membrane could be made from a polymer which generally have low thermal conductivity as evidenced by Huang. Vollmer additionally teaches that temperature gradients could be applied to the vertical sperm sorting method for beneficial effects. Thus, one having ordinary skill in the art would have every reason to believe that a temperature gradient as taught by Perez-Cerezales could be applied to the method as taught by Vollmer without changing the size of the device and that the porous membrane and channel system of Vollmer would be able to maintain a temperature difference over a small distance with use of various membrane thicknesses. It must be noted, Applicant has not claimed a thickness or material of the porous membrane, nor the dimensions of the thermal gradient, nor have they excluded the thermal gradient traversing not just the membrane but across the channel system as well.
In regard to Applicant’s assertion that the increase in the values of VAP, VSL, and VCL based on the instant method could not have been predicted from the combination of Vollmer and Perez-Cerezales, Perez-Cerezales teaches that the values of VAP, VSL, and VCL of human sperm were increased in response to sperm sorting by thermotaxis as compared to control (Table 1). Thus, Applicant’s instant results are in line with what would be expected based on the teachings of Perez-Cerezales. Furthermore, in response to Applicant's argument that the references fail to show certain features of Applicant’s invention, it is noted that the features upon which applicant relies (i.e., values of VAP, VSL, and VCL of human sperm) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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