DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ response of 5/12/2026 has been received and entered into the application file. Claims 1-17 remain pending, all of which have been considered on the merits.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-17 under 35 USC 112(b): The amendments to claims 1 clarifies the scope of claim 1. The rejection thereof is withdrawn.
RE: Rejection of claims 1-3, 7 and 14-17 under 35 USC 102(a)(1) over Durack et al:
Applicants have traversed the rejection of record over Durack et al on the grounds that Durack et al do not teach the step of resuspending the concentrated sperm sample in a freezing extender comprising the polyalcohol. Applicants assert that Durack et al only teach resuspending the concentrated sperm in a resuspension fluid consisting of TCA with 10% egg yolk or Delbecco’s [sic] PBS.
In response, it appears Applicants are referencing “Centrifugation Examples I-V” on Pages 106-111 of Durack et al. It is acknowledged that these examples use a resuspension fluid consisting of TCA with 10% egg yolk or PBS, not a cryoextender comprising a polyalcohol. These examples do not add a cryoextender, as they are focused solely on effect of centrifugation on sperm motility. However, within the section titled “Cryoextension” (See Pg 114-121), additional details about timing of adding the cryoextender are disclosed. Specifically, Durack et al teaches the sperm concentration (following the concentration step) can be adjusted by adding resuspension fluid, buffers and/or extenders (See Pg. 116, ln 22-24). Referencing the flow chart of Fig. 103, Durack et al teach that the sperm can be resuspended in a resuspension fluid containing a protein source and then a cryoprotectant can be added (See Pg. 116, ln 17-27 & Fig. 103), or an extender including both the cryoprotectant and protein source can be added together to resuspend the sperm (See Pg 119, ln 27-30; See Pg. 120, ln 13-17). The latter option reads on the current claims. Furthermore, in the “Multichannel Sorting Example II” at Pg 139-140, Durack et al use Triladyl® (which contains cryoprotectant glycerol, a polyalcohol) as a resuspending fluid (See Pg 140, ln 15-18). Therefore, Durack et al do teach that the cryoextender, including glycerol (a polyalcohol) can be added as part of the resuspension fluid.
The rejection has been adjusted to address the modified claims.
RE: Rejection of claims 1-17 under 35 USC 103 over Durack et al:
Applicants assert Durack et al do not teach all claim limitations, as above, and thus do not render obvious the claims.
For the reasons discussed above the anticipation rejection is considered proper. The remaining of the obviousness rejection is thus maintained (adjusted to address modified claims).
RE: Rejection of claims 1-17 on grounds of NSDP over claims of US Patent 11279913: Applicants submitted a terminal disclaimer over US Patent 11279913. The terminal disclaimer has been approved and recorded. The rejection is withdrawn.
RE: Provisional rejection of claims 1-17 on grounds of NSDP over copending application 19/209325, in view of Durack et al:
Applicants submitted a terminal disclaimer over US Patent Application 19/209325. The terminal disclaimer has been approved and recorded. The rejection is withdrawn.
Duplicate Claim Warning
Applicant is advised that should claim 3 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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). Though worded differently, both claims attempt to further limit the step of collecting the manipulated sperm sample in a media comprising a polyalcohol to involve collecting the manipulated sperm sample and the polyalcohol in a container.
Claim Rejections - 35 USC § 112
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 12-15 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.
Each of claims 12-15 refer to “the step of collecting the manipulated sperm sample in the presence of a polyalcohol…” there is insufficient antecedent basis for this step, as claim 1 has been amended to change the language to recite a step of collecting the manipulated sperm sample in a media comprising a polyalcohol.
Furthermore, given that claim 1 now clarifies that the step of collecting the manipulated sperm sample involves collecting the manipulated sperm into a media comprising the polyalcohol (i.e. limiting the collection media to comprising a polyalcohol), it is unclear this collecting step would further include steps related to the stain or sheath media. If claims 12, 13 and 15 intend to further limit the overall method to require the inclusion of polyalcohol in a staining media or a sheath fluid, such should be claimed. As written, the claims are considered unclear as to whether or not other media used throughout the method are limited.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 3 and 14 have the same scope: they further limit the step of collecting the manipulated sperm sample in a media comprising a polyalcohol to involve collecting the manipulated sperm sample in a container with the polyalcohol. Due to their structure, sperm and a media comprising polyalcohol must be contained in a container. Therefore, claims 3 and 14 simply recite a feature which would be inherently required by the method fo claim 1. The recitation of an inherent features does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durack et al (WO 04/088283).
Durack et al disclose an improved system (method and apparatus) for commercial processing of animal semen, which serves to collect sperm, sort sperm by gender via flow cytometry, and then cryopreserve the sorted sperm (See Pg 4, ln 14-27). The overall process is diagrammed in Fig. 1, the process comprises, inter alia, collecting a sperm sample (39), staining the sperm sample with a staining fluid (48, 49), contacting the stained sperm with a sheath fluid (54), sorting the sperm (55), collecting the sorted sperm in a collection fluid (57), concentrating the sorted sperm (58B), adding cryoextender (58C), then cryopreserving the sorted sperm (61) (See Fig. 1, and Pg 22, ln 10-Pg 23, ln 24).
In more detail, the staining step (49) involves staining the sperm with a staining mixture (See Pg 28, ln 5-29).
The sorting step (55) involves introducing the stained sperm as a sample fluid into the nozzle of a flow cytometer and injecting a stream of the stained cells in the sample fluid into a stream of sheath fluid (See Pg 30, ln 1-Pg. 31, ln 9). Flow cytometry is used to sort sperm based on DNA content, particularly discrimination based on X and Y chromosome bearing sperm (See Pg 31, ln 10- Pg 32, ln 30).
The collecting step (57) involves collecting the sorted sperm into a collection fluid (58A) in a collection vessel (See Pg. 103, ln 29-33). Alternatively, the sorted sperm can be collected into a vessel containing a cryoextender. An exemplified cryoextender is Triladyl (glycerol, tris, citric acid, fructose, tylosin, gentamycin, spectinomycin and lincomycin), egg yolk, and pyruvic acid. The collection vessel can be a centrifugation tube (See Pg 107, ln 14-17).
The concentrating step (58B) can involve centrifugation (See Pg 106, ln 25-Pg 107, ln 35). When the sorted sperm are collected into a centrifugate tube (as the collection vessel), the sperm in the collection fluid can be centrifuged directly in the centrifugation tube with the collection fluid.
When sperm are to be cryopreserved for future use, the concentrated sperm are resuspended for further processing. The step of adding the cryoextender (58C) can serve to resuspend the concentrated sperm. In further detail, Durack et al teach the sperm can be resuspended in a resuspension fluid containing a protein source and then a cryoprotectant can be added (See Pg. 116, ln 17-27 & Fig. 103), or Durack et al teach an extender including both the cryoprotectant and protein source can be added together to resuspend the sperm (See Pg 119, ln 27-30; See Pg. 120, ln 13-17). The “Multichannel Sorting Example II” at Pg 139-140 also shows Triladyl® (which contains cryoprotectant glycerol, a polyalcohol) being added as a resuspending fluid (See Pg 140, ln 15-18). Durack et al teach the cryoextender added in step (58C) can comprises a buffer, or buffered solution, a protein source and a cryoprotectant. The cryoprotectant can be, inter alia, glycerol. The cryoprotectant is added to be present in the cryoextender at a concentration of preferably 6% v/v (See Pg 114, ln 23-Pg 115, ln 13).
The cryopreservation step (61) involves sequentially adding a protein source, cooling the sperm to a temperature of about 4-5oC, adding a cryoprotectant, such as glycerol, allowing the sperm to equilibrate with the cryoprotectant, then supercooling the sperm to -196oC (See Pg. 115, ln 24-Pg 116, ln 2). The duration of the equilibration can be 30 minutes (See Pg. 116, ln 25-35).
Regarding claim 1: The process illustrated in Fig. 1, involves freezing a manipulated sperm sample.
The sperm collected from a bull (step 39) reads on a sample having viable X-chromosome bearing sperm and viable Y-chromosome bearing sperm.
The step of staining the sperm (48, 49) serves to generate a stained sperm sample.
The step of sorting the sperm via the flow cytometer (55) involves contacting a stained sperm sample with a sheath fluid in a flow path. The action of the flow cytometer serves to manipulate the ratio of viable X-chromosome bearing sperm to viable Y-chromosome bearing to form at least one manipulated sperm population.
The step of collecting the manipulated sperm into a collection vessel (57) comprising a cryoextender, wherein the cryoextender comprises glycerol (as part of Triladyl), reads on collecting the manipulated sperm sample in a media comprising a polyalcohol (glycerol being an example of a polyalcohol).
The concentrating by centrifugation step (58B) reads on concentrating the collected sperm sample.
The step of resuspending the concentrated sperm by adding a cryoextender (58C), wherein the cryoextender comprises both a protein source and a cryoprotectant, reads on resuspending the concentrated sperm in a freezing extender. They cryoextender can include glycerol (as part of Triladyl) which is a polyalcohol.
The step of cryopreserving the sperm (61) reads on freezing the resuspended sperm sample.
Regarding claim 2: Following the discussion of claim 1 above, as part of the cryopreservation step (61), Durack et al discloses cooling the sperm to 4-5oC while allowing the sperm to equilibrate to the cryoprotectant. Durack et al teach the period of time at which the sperm and cryoprotectant are held together prior to freezing can be 30 min (See Pg. 25-33)..
Regarding claim 3: Following the discussion of claim 1 above, the manipulated sperm can be collected directly into a centrifugation tube, which will read on collecting the manipulated sperm in a container.
Regarding claim 7: Following the discussion of claim 1 above, the manipulated sperm can be collected directly into a centrifugation tube [containing the cryoextender], thus the sperm can be concentrated following collecting …without any further dilution occurring between the steps.
Regarding claims 14 and 15: Following the discussion of claim 1 above, the sperm can be collected directly into a container comprising the cryoextender. The cryoextender can comprise glycerol. In this case, the cryoextender serves as the collection media. Thus the step of collecting the manipulated sperm involves collecting the manipulated sperm in a container having a collection media comprising the glycerol [polyalcohol].
Regarding claims 16-17: The action of the flow cytometer to sort the sperm based on X- or Y-chromosomes meets the limitations of claims 16-17.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as unpatentable over Durack et al (WO 04/088283).
The teachings of Durack et al are set forth above. Durack et al anticipates claims 1-3, 7 and 14-17.
Regarding claim 4: Following the discussion of claim 3 above, Durack et al disclose collecting the sorted sperm into a collection vessel, the collection vessel can be a centrifugation tube. Durack et al does not disclose the volume of the collection vessel. However, official notice is taken that standard centrifugation tubes exist with capacities of 5 mL to 50 mL. Selection of the size of the vessel is dependent on the amount of sample being processed. Selection of any appropriately sized vessel would have been prima facie obvious.
Regarding claim 5: Following the discussion of claim 4 above, the degree of filling of the centrifugation vessel is again a matter of routine optimization. The tube’s size will be selected based on the volume of sample expected to be collected, selecting a tube with a capacity to fill 60% to 90% is well within the purview of the skilled artisan and would be appropriate for proper centrifugation.
Regarding claim 6: Following the discussion of claim 5 above, Durack et al teaches the concentrating step (centrifugation) can be performed in the collection vessel.
Regarding claims 8-10: Following the discussion of claim 1 above, Durack et al teaches adding a cryoextender to the concentrated sperm. The cryoextender reads on a freezing extender. The cryoextender comprises a cryoprotectant. The cryoprotectant can comprise glycerol. 6% v/v cryoprotectant in the cryoextender is disclosed.
The claims differ from the method of Durack et al in that claim 8 requires less than 6% v/v polyalcohol, and claims 9-10 require slightly lower concentrations. However, the disclosure of 6% v/v is considered sufficiently close to less than 6% v/v that a prima facie case of obviousness exists. Furthermore, optimization of the concentration of the cryoprotectant would have been a matter of routine optimization, as the concentration of cryoprotectant directly affects the survivability of cells during/after freezing. Absent evidence of criticality, the claimed concentrations are considered prima facie obvious over the disclosed concentrations of Durack et al.
Regarding claim 11: Following the discussion of claim 1 above, as part of the cryopreservation step (61), Durack et al discloses cooling the sperm to 4-5oC while allowing the sperm to equilibrate to the cryoprotectant. Durack et al teach the period of time at which the sperm and cryoprotectant are held together prior to freezing can be anywhere from 60 minutes to many hours (See Pg. 115, ln 37-Pg 116, ln 16).
This differs from claim 11, which requires the holding period prior to freezing to be 2 to 18 hrs. However, the duration of the equilibration period would be a matter of routine optimization to ensure equilibration of the sperm. The alternative embodiment gives a starting period, and optimization based on this value would have been within the purview of the artisan of ordinary skill.
Regarding claims 12-13: For the reasons set forth above, claims 12-13 do not clearly correlate with amended claim 1. However, in so far as claims 12-13 can be interpreted to mean the overall method further comprises adding the polyalcohol to the sperm sample during a step of staining (claim 12) or adding the polyalcohol to the sheath fluid which is collected together with the sperm sample in the collecting step (claim 13), the following rejection is made:
Durack et al does not discuss including glycerol or any cryoprotectant in the staining media or sheath fluid in the process of Fig. 1.
However, in a separate section, Durack et al disclose an alternative procedure involving cryopreservation of sperm cells (See Pg 229, ln 20-Pg 233, ln 3 (A1’-A40)). The details of this cryopreservation protocol are considered at least obvious variants/alternatives which could be employed in the process of Fig. 1. In this alternative embodiment Durack et al disclose the cryoprotectant can be glycerol (See Pg 230, ln 1-2 (A5’)). Durack et al disclose the cryoprotectant can be added to a sheath fluid that is used in the flow cytometry to analyze and sort the sperm cells (See Pg. 231, ln 30-36, (A27’-A28’)).
Based on this teaching, it would have been prima facie obvious to have provided glycerol to the sperm at any point during the processing of the sperm, including during the staining or as part of the sheath fluid. The sperm are to be provided with cryoprotectant, so the time point of provision of the cryoprotectant is considered a matter of experimental design. The alternative embodiment of Durack et al at least suggests that the timing of provision of the cryoprotectant is not critical. Absence to the contrary would be effective to move prosecution forward.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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