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 .
The preliminary amendment filed 10/7/2022 has been received and entered into the application file. Claims 1-17 are pending, all of which have been considered on the merits.
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 120 as a continuation of prior-filed US application 15/875679 (filed 1/19/2018, now US Patent 11279913), which claims benefit of prior-filed US Provisional applications 62/584557 (filed 11/10/2017) and 62/448829 (filed 1/20/2017).
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 1-17 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.
Regarding claim 1: The step “collecting the manipulated sperm in the presence of a polyalcohol” is unclear. It is not clear what “in the presence of a polyalcohol” requires. Specifically, it is unclear if the claim is requiring the sperm to be collected into a collection media, and for the collection media to comprise a polyalcohol, if the polyalcohol can be present within the sheath fluid (and thus at least a portion will be retained upon collection of the manipulated sperm population), or if the claim only requires the presence of polyalcohol in some other capacity (e.g. present in the lab, etc). Clarification is required.
Claims 2-17 depend directly or indirectly from claim 1, inherit the deficiency, and so are rejected on the same basis.
Regarding claim 3: There is insufficient antecedent basis for the limitation “the step of collecting a mixture” and “collecting the mixture in a container”. Parent claim 1 describes collection of a manipulated sperm sample. Correction is required. It is acknowledged that the manipulated sperm sample is collected in the presence of a polyalcohol, so a mixture could be formed. However, since there is no clear step of “collecting a mixture”, the language is problematic as written.
Claims 4-6 depend directly or indirectly from claim 3, inherit the deficiency, and so are rejected on the same basis.
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 seme, 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) involves 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.
The cryoextender (58C) 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 the presence of 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 adding the cryoextender (58C) reads on resuspending the concentrated sperm in a freezing extender.
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.
Regarding claim 3: Following the discussion of claim 1 above, the 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 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: 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11279913, in view of Durack et al (WO 04/088283).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
Regarding claims 1, 14, 15, 16 and 17: Patented claim 17 recites a method comprising, staining a sperm sample with a staining media; injecting the stained sperm into a flow of sheath fluid, which reads on contacting stained sperm with a sheath fluid in a fluid path; exposing the stained sperm … to electromagnetic radiation source which cases a detectable response in the DNA selective dye; detecting the response of the DNA selective dye to the electromagnetic radiation exposure; manipulating a ratio of viable X-chromosome bearing sperm to viable Y-chromosome bearing sperm to form at least one manipulated sperm population; and collecting the at least one manipulated sperm population in one or more collection vessels comprising collection media therein. Patented claim 1 requires the collection media to comprise a cryoprotectant comprising a polyalcohol. Thus the manipulated sperm is collected in the presence of a polyalcohol.
The patented claim differs in that it does not require steps of concentrating the collected sperm sample, resuspending the concentrated sperm sample in a freezing extender or freezing the resuspended sperm sample.
The teachings of Durack et al are set forth above. Durack et al teach a very similar method of processing sperm to separate based on X- and Y-bearing chromosomes (See Fig. 1). Durack et al teach after collection of the manipulated sperm population, the sperm are concentrated, a cryoextender comprising a cryoprotectant is provided thereto (reads on resuspending in a freezing extender), and the sperm are cryopreserved (freezing the resuspended sperm). It is submitted that the steps not taught by the patent are standard processing steps for preservation of sperm following sex sorting (manipulation based on X- and Y-chromosome). It would have been prima facie obvious to one having ordinary skill in the art to submit the sorted sperm of the patent to the further standard processing steps in order to permit storage and shipping of the sperm to other locations for use.
Regarding claims 2-11: Following the discussion of claim 1 above, and as set forth above in the 103 rejection, Durack et al teach or render obvious each of the processing steps/details of claims 2-11. Each of these additional processing steps/details are considered prima facie obvious.
Regarding claims 12-15: Patented claim 1 requires the polyalcohols be present in both the staining media, sheath fluid and the collection media.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/209325 (reference application), in view of Durack et al (WO 04/088283).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims render obvious the instant claims as follows:
Regarding claims 1, and 14-15: Copending claim 1 requires contacting a stained sperm cell sample with a sheath fluid in a flow path; manipulating a ratio of viable X-chromosome bearing sperm cells to viable Y-chromosome bearing sperm cells in the stained sperm sample to form at least one manipulated sperm cell sample; collecting the manipulated sperm cell sample; concentrating the manipulated sperm cell sample; and resuspending the concentrated sperm cell sample in a media comprising erythritol. Copending claim 4 requires that the sample is collected into a collection media comprising erythritol. Erythritol is a polyalcohol.
Copending claim 4 differs from instant claim 1 in that it does not teach a further step of freezing the resuspended sperm. However, Durack et al, teachings set forth above, teaches that it is standard to cryopreserve sorted sperm samples to permit for storage and shipping (See Durack et al, Pg. 115, ln 24-36). Therefore it would have been prima facie obvious to have further carried out a step of freezing the resuspended sperm sample following the copending claim methods to permit for storage and shipping.
Regarding claims 2-11: Following the discussion of claim 1 above, and as set forth above in the 103 rejection, Durack et al teach or render obvious each of the processing steps/details of claims 2-11. Each of these additional processing steps/details are considered prima facie obvious.
Regarding claims 12-15: Following the discussion of claim 1 above, copending claim 2 teaches the method can further comprise providing erythritol to the staining media and/or sheath fluid.
Regarding claims 16-17: Following the discussion of claim 1 above, at least Durack et al teach the details of a flow cytometer which would perform the actions of claims 16 and 17. Selection of the flow cytometer of Durack et al for the manipulation step of the copending claims is prima facie obvious, as it is substitution of a device capable of performing the disclosed task.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/ALLISON M FOX/Primary Examiner, Art Unit 1633