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 .
Claims status
Applicant’s reply filed 9/16/2026 is acknowledged.
Claims 1, 3, 10-15 is/are currently pending and is/are under examination.
Claim Rejections - 35 USC § 103 - Maintained
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.
Claim(s) 1, 3, 10-15 remain rejected under 35 U.S.C. 103 as being unpatentable over Durack et al (US 2011/0217722 A1, Sep 8, 2011; ref of record).
Regarding claim 1, Durack teaches a method of processing sperm cells for sex-sorting ([002, 008, 012, 014, 760], Q. Sperm Sorting Method Including High-Recovery Sort Strategy). Durack teaches their method is applicable for porcine species [762, 763].
The method comprises:
forming a stream comprising sperm cells in a sample media (=first media) encased in sheath media (Figure 1, steps 53-54; [792], [794]),
determining specified DNA characteristics, such as presence of X or Y chromosome, in the sperm cells and
sorting/selecting the sperm cells according to the specified DNA characteristics (Figure 1, step 55),
collecting the desired subpopulation in a collection media (=second media) (Figure 1, step 57-58).
Durack teaches a sperm cell staining step prior to the forming the stream that allows for distinguishing sperms cells with X vs Y chromosome based on fluorescence intensity during the determining step of their method [0784]. Durack teaches that desired DNA characteristics, such as presence of X or Y chromosome, can be distinguished by their method that comprises photodetector [795, 802-804].
Durack teaches several media for sperm cells that comprise buffers along with additives [766-774]. Durack teaches “One or more energy sources may be added to minimize or inhibit the sperm cells from oxidizing intracellular phospholipids and other cellular components. Exemplary energy sources include monosaccharides, such as fructose, glucose, galactose and mannose, and disaccharides, such as sucrose, lactose, maltose, and trehalose, as well as other polysaccharides. For example, the resulting sperm suspension may include about 1 % (w/v) to about 4% (w/v) of the energy source(s ).” [770]
For the sample media (=first media), Durack teaches media such as PBS, Na citrate, HEPES, TL that comprise no sugar additive (i.e. 0mM sugar), other media such a TCA#1, TCA#2 and TEST that comprise ~70mM fructose, ~15mM fructose and ~11mM glucose sugar additives respectively ([766], Table 1; TCA#1 has 12.5g/L fructose = ~70mM, TCA#2 has 2.67g/L fructose = ~15mM, TEST has 2g/L glucose = ~11mM).
Although Durack does not teach a first media with 10mM glucose, Durack teaches a first media with a concentration of glucose (11mM) that is approaches the claimed glucose concentration (10mM). According to MPEP 2144.05 (I), “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” In the instant case, Durack’s 11mM glucose is so close to the claimed 10mM glucose that a skilled artisan would expect Durack’s first media to have the same properties as the claimed media. Therefore, in teaching a first media with 11mM glucose, Durack renders the instant claim that recites a first media with 10mM glucose prima facie obvious.
Regarding claim 3, for collection media (=second media), Durack teaches that “the collection fluid may also contain a range of additives that are beneficial to sperm viability or motility. Examples of such additives include an energy source” [1048]. Regarding energy sources, Durack teaches “One or more energy sources may be added to minimize or inhibit the sperm cells from oxidizing intracellular phospholipids and other cellular components. Exemplary energy sources include monosaccharides, such as fructose, glucose, galactose and mannose, and disaccharides, such as sucrose, lactose, maltose, and trehalose, as well as other polysaccharides. For example, the resulting sperm suspension may include about 1 % (w/v) to about 4% (w/v) of the energy source(s ).” [770]. An exemplary collection media taught by Durack comprises Dulbecco’s PBS or Na citrate based media along with additives such as 1% (w/v) fructose (= 10g/L fructose = ~56mM; [1045, 1048, 1049]).
Although Durack does not explicitly teach a collection media with 1-10mM glucose, Durack teaches the equivalency of fructose and glucose in sperm media as energy sources [770]. Furthermore, identification of optimal sugar, fructose or glucose, concentration in a sperm media is routine in the art.
According to MPEP 2144.06 (II), substituting equivalents known for the same purpose is prima facie obvious. See Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.). In the instant case, Durack itself provides evidence that both glucose and fructose were considered equivalent in the art with both monosaccharides performing the function of an energy source to the sperm cells [770].
According to MPEP 2144.05 (II), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” and “"It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").” In the instant case, Durack teaches an exemplary collection media with 56mM fructose [1049], however identification of a lower sugar concentration, such as 1-10mM glucose, could be done using routine lab techniques such as by making buffers with different sugars at different concentration and identifying cells with the desired characteristics. Such a method would be considered routine by an ordinary artisan. Therefore, in teachings a collection media with a sugar, such as fructose, at 56mM, Durack renders a collection media with an equivalent sugar, such as glucose, at a concentration of 1-10mM optimized using routine methods prima facie obvious.
Regarding claim 10, Durack teaches a sorting step which isolates selected sperm cells from the unselected sperm (Figure 1, step 57 in [761] is collecting sorted cells, [795] describes sorting system 119 for separating sorted population, [850]).
Regarding claims 11 and 12, Durack teaches media additives for regulating oxidation/reduction reactions to protect sperm cells (=OSRs) such as pyruvate, vitamin K, lipoic acid, glutathione, flavins, quinones, superoxide dismutase (SOD), and SOD mimics [0774].
Regarding claims 13 and 14, Durack teaches centrifugation step to concentrate the collected subpopulation [1056, 1058, 1061, 1063]. In order to test centrifugation parameters, Durack resuspends the centrifuged concentrated sperm cells in a Tris Citric Acid media with yolk proteins [1058, 1061, 1063]. However, the purpose of centrifugation is to concentrate the sperm for further use in artificial insemination or for cryopreservation (step 58 in [761], [1056]). Durack teaches suspending concentrated sperm in collection fluid such as cryoextenders and additive such as energy sources, i.e. sugars, and regulators of oxidation/reduction reactions, i.e. OSRs (= third media; step 58 in [761], sugars as energy sources in [770], OSRs in [0774]). A sample collection fluid may comprise 1% w/v fructose (= 10g/L fructose = ~56mM) and OSRs such as pyruvate, vitamin K or lipoic acid [1049].
Although Durack does not explicitly teach a collection media with 1-20mM glucose, Durack teaches the equivalency of fructose and glucose in sperm media as energy sources [770]. Furthermore, identification of optimal sugar, fructose or glucose, concentration in a sperm media is routine in the art.
According to MPEP 2144.06 (II), substituting equivalents known for the same purpose is prima facie obvious. See Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.). In the instant case, Durack itself provides evidence that both glucose and fructose were considered equivalent in the art with both monosaccharides performing the function of an energy source to the sperm cells [770].
According to MPEP 2144.05 (II), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” and “"It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").” In the instant case, Durack teaches an exemplary collection media with 56mM fructose [1049], however identification of a lower sugar concentration, such as 1-20mM glucose, could be done using routine lab techniques such as by making buffers with different sugars at different concentration and identifying cells with the desired characteristics. Such a method would be considered routine. Therefore, in teachings a collection media with a sugar, such as fructose, at 56mM, Durack renders a collection media with an equivalent sugar, such as glucose, at an concentration of 1-20mM optimized using routine methods prima facie obvious.
Regarding claim 15, Durack teaches a method of processing sperm cells for sex-sorting ([002, 008, 012, 014, 760], Q. Sperm Sorting Method Including High-Recovery Sort Strategy). Durack teaches their method is applicable for porcine species [762, 763]. The method comprises forming a stream comprising sperm cells in a sample media (=first media) encased in sheath media (Figure 1, steps 53-54; [792], [794]), determining specified DNA characteristics in the sperm cells and sorting the sperm cells according to the specified DNA characteristics using laser ablation based sorting which ablates cells with undesired characteristics (Figure 1, step 55; [1213-1215]) (Figure 1, step 57-58). Durack teaches a sperm cell staining step prior to the forming the stream that allows for distinguishing sperms cells with X vs Y chromosome based on fluorescence intensity during the determining step of their method [0784]. Durack teaches that desired DNA characteristics, such as presence of X or Y chromosome, can be distinguished by their method that comprises photodetector [795, 802-804].
For the sample media (=first media), Durack teaches media such as PBS, Na citrate, HEPES, TL that comprise no sugar additive (i.e. 0mM sugar), other media such a TCA#1, TCA#2 and TEST that comprise ~70mM fructose, ~15mM fructose and ~11mM glucose sugar additives respectively ([766], Table 1; TCA#1 has 12.5g/L fructose = ~70mM, TCA#2 has 2.67g/L fructose = ~15mM, TEST has 2g/L glucose = ~11mM).
Although Durack does not teach a first media with 10mM glucose, Durack teaches a first media with a concentration of glucose (11mM) that is approaches the claimed glucose concentration (10mM). According to MPEP 2144.05 (I), “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” In the instant case, Durack’s 11mM glucose is so close to the claimed 10mM glucose that a skilled artisan would expect Durack’s first media to have the same properties as the claimed media. Therefore, in teaching a first media with 11mM glucose, Durack renders the instant claim that recites a first media with 10mM glucose prima facie obvious.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Response to Arguments
Applicant's arguments filed 9/16/2026 regarding U.S.C. 103 rejection of the claims have been fully considered but they are not persuasive.
Applicant allege that example 6 in the specification demonstrates the criticality of the concentration of glucose recited in the claims (10mM) because 10mM yields highest 96-hour motility and second highest viability compared to concentration that are greater than and less than 10mM (page 4, para 5). Further, Applicant allege that “the experimental results do not demonstrate a simple monotonic relationship in which increasing or decreasing glucose concentration produces a correspondingly predictable change in viability or motility” (page 5, para 1). Thus, Applicant argue that it would not predictable that 10mM and 11mM would be equivalent (page 5, para 1).
In response, as noted by the Applicant, example 6 tests 0, 1, 5, 10, 25 and 50mM glucose in catch and sheath media. The results show that for each concentration motility, viability reduce and DIA increase over the 96-hour period (Table 20, 21, 22). The three-way ANOVA results show that both treatment and time are statistically significant factors for each of these parameters, and a statistically significant interaction exists between these two factors. No data is presented that shows that 10mM concentration is statistically superior to other concentrations tested, for example by a post-hoc statistical analysis. There is no evidence that 10mM concentration achieves superior or unexpected results, that further is both statistically and practically significant (MPEP 716.02(b)). Although the numerical value for motility is highest for 10mM at 96-hours, this does not suggest that this numerical value is statistically significant or that the difference in motility for 10mM in comparison to other concentrations tested is of any practical significance. Furthermore, 10mM does not even produce the highest numerical value for viability and DIA. Thus, criticality of 10mM concentration is not established. A skilled artisan does not expect significant differences in processed porcine sperm based on glucose concentration. This is especially so when the difference in glucose concentration is as small as the difference between the glucose concentration of the claims and the prior art (i.e. just 1mM). The difference in concentrations tested in the instant specification is much higher than the minimal difference in concentration between the claim and the prior art. The example in the specification test 5, 10 and 25mM while the prior art concentration of 11mM differs from the claimed concentration of 10mM by just 1mM. There is no evidence that a skilled artisan would expect that by simply changing the prior art concentration from 11 to 10mM, the sheath and catch media would lose their functionality considering that there is no evidence that 10mM is a critical concentration.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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/MATASHA DHAR/Examiner, Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
