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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31 December 2025 has been entered.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-5 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Vollmer (US 20180282676) in view of Cerezales “Sperm selection by thermotaxis improves ICSI outcome in mice” (cited in the 6/8/2022 IDS).
With respect to claim 1, Vollmer discloses an apparatus for processing sperm comprising an upper chamber (Figure 1A:42) and a bottom chamber (Figure 1A:12) arranged vertically. A collection port (Figure 2B:A4) is connected to the upper chamber, and an injection port (Figure 2B:A1) is connected to the bottom chamber. Vollmer teaches that a porous layer (Figure 1A:20) is placed at an interface between the upper and bottom chambers to allow particles to communicate between them. This is taught in paragraphs [0090]-[0101]. Paragraph [0065] further discusses that a temperature gradient is produced between the upper and bottom chamber (“The selective separation of a biological active component in the biological sample may furthermore be facilitated by other methods. For example, temperature, temperature gradients, or the application of an electromagnetic field may provide an increased, enriched, and/or faster separation, e.g., of highly motile spermatozoa”). Although this strongly implies the use of a temperature control unit, Vollmer does not expressly state that a temperature control unit comprising a heating source maintains the temperature of the upper chamber higher than that of the bottom chamber.
Cerezales teaches a method in which motile sperm are selected through thermotaxis. Cerezales teaches that swim-up techniques are improved when a thermal gradient is applied. This is described in the Introduction. The Results section describes how a collection chamber is maintained at a higher temperature than an injection chamber using a temperature control unit comprising a heating source, and that this allows sperm to migrate to the higher temperature location. See also Fig. 1.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Vollmer upper chamber at a higher temperature than the bottom chamber and to ensure that the porous layer is configured to delay thermal equilibrium therebetween. Cerezales teaches that swim-up sperm selection assays are improved when a thermal factor is introduced to take advantage of the sperm’s natural inclination to migrate to warmer temperature locations. Vollmer already states that a thermal gradient may be applied between the upper and bottom chamber, and one of ordinary skill would have understood how to accomplish this using a temperature control unit, especially in view of the teachings of Cerezales.
Vollmer additionally teaches in paragraph [0121] that the height of the separation layer 20 is in the range of 0.5 to 5 mm. In the event that a temperature gradient applied to Vollmer is defined by the height of the separation layer 20, Vollmer clearly teaches embodiments in which the gradient extends “a distance of about 4 mm”. In the event that a temperature gradient applied to Vollmer is defined by both the height of the separation layer 20 and the channel layer 30, then Vollmer still contemplates embodiments in which the gradient extends “a distance of about 4 mm”. If the height of the separation layer 20 is approximately 1.5 mm and the height of the cahnnel layer is shown as being approximately twice as long as the heigh of the separation layer 20, then Vollmer arrives at a thermal gradient length of about 4.0 to 4.5 mm.
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It would have been well within the ability of one of ordinary skill to consider all lengths within the range of 0.5 to 5 mm disclosed by Vollmer, including those lengths that produce a temperature gradient of approximately 4 mm.
With respect to claim 3, Vollmer and Cerezales disclose the combination as described above. Vollmer states in paragraph [0091] that the porous layer is a biocompatible semipermeable membrane.
With respect to claim 4, Vollmer and Cerezales disclose the combination as described above. Vollmer states in paragraph [0044] that polycarbonate materials are used to create the sperm processing device. Accordingly, those of ordinary skill would have considered fabricating the semipermeable membrane from polycarbonate, especially given that this is known in the art as an inexpensive, biocompatible and easily machined material.
With respect to claim 5, Vollmer and Cerezales disclose the combination as described above. Vollmer teaches in paragraph [0032] that the porous layer is characterized by individual pore diameters as low as 20 microns.
With respect to claim 9, Vollmer and Cerezales disclose the combination as described above. Vollmer teaches a corresponding method in which unsorted sperm are injected into the bottom chamber through the injection port and a compatible buffer is injected into the upper chamber through the collection port. See paragraph [0057]. Incubation is conducted for a period, and sorted sperm are harvested from the upper chamber through the collection port. Vollmer teaches in paragraph [0065] that a temperature gradient may be applied, as does Cerezales.
With respect to claim 10, Vollmer and Cerezales disclose the combination as described above. As discussed above, it would have been obvious to ensure that a heating source is in thermal contact with the upper chamber, especially in view of Cerezales.
With respect to claims 11 and 12, Vollmer and Cerezales disclose the combination as described above. Cerezales recommends in the Results section setting a temperature gradient of 3°C from 35°C to 38°C.
With respect to claim 13, Vollmer and Cerezales disclose the combination as described above. Vollmer discusses in paragraph [0064] that the incubation period is between 15-30 minutes.
With respect to claim 14, Vollmer and Cerezales disclose the combination as described above. Vollmer states in paragraph [0035] that the buffer may be any medical grade buffer. Those of ordinary skill would have therefore considered bicarbonate and/or HEPES, as both are very common buffers used in biology1.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vollmer (US 20180282676) in view of Cerezales “Sperm selection by thermotaxis improves ICSI outcome in mice” as applied to claim 1, and further in view of Tasoglu (US 20200368745) and Deutsch (US 20090111141).
Vollmer and Cerezales disclose the combination as described above, however Vollmer does not appear to teach a venting feature.
Tasoglu discloses an apparatus for processing sperm comprising an upper chamber and bottom chamber that are vertically arranged. See Fig. 1. A porous layer (Figure 1:75) is placed between the upper and bottom chamber. Paragraphs [0010] and [0038] state that a plurality of through-holes (Figure 1:13) arranged as a vent strip are provided on a ceiling feature (Figure 1:20) to provide the venting of gases. Tasoglu expressly states that “any suitable number, position, pattern, and/or size of vent holes is contemplated herein”.
Deutsch discloses a system for studying cells comprising an upper chamber (Figure 5A:92) having an inclined and curved ceiling that communicates with a through-hole (Figure 5A:94) configured to ventilate the upper chamber. This is taught in paragraphs [0116]-[0121].
Before the effective filing date of the claimed invention, it would have been obvious to provide the Vollmer upper chamber with an inclined ceiling having a strip vent and/or a plurality of through-holes. Tasoglu teaches in paragraph [0038] that venting is important in sperm motility assays because it enables fluid flow through the system and provides for the removal of interfering bubbles. Deutsch further states that an upwardly sloping wall is useful because it serves to direct gas towards the vent outlet (“air in upper chamber 92 follows the slope of the upper wall of upper chamber 92 to excess gas storage section 86 and out through vent 94”), which improves gas removal from the system.
Response to Arguments
Applicant's arguments filed 31 December 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the claimed invention is characterized by high throughput and high sorting quality, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Furthermore, it is noted that the Vollmer apparatus is nearly structurally identical to the claimed invention and therefore is characterized by a similar operation and capable of obtaining similar results. For the reasons expressed in the rejection above, Vollmer clearly shows that the distance between the upper chamber and the lower chamber may be approximately 4 mm (“a height substantially corresponding to a height of the separation layer 22 in the range of 0.5 to 5 mm, preferably between 1 and 3 mm”). Vollmer additionally teaches in paragraph [0065] that the chamber is designed to be used with an applied temperature gradient generated by a heat source (“The selective separation of a biological active component in the biological sample may furthermore be facilitated by other methods. For example, temperature, temperature gradients, or the application of an electromagnetic field may provide an increased, enriched, and/or faster separation, e.g. of highly motile spermatozoa”, emphasis added).
Conclusion
This is a non-final rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
1 https://en.wikipedia.org/wiki/Buffer_solution