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 .
Information Disclosure Statements
The information disclosure statements (IDS) submitted 02/12/2026, 12/16/2024, 07/02/2024, 06/14/2024, 02/20/2024, 02/20/2023, 09/19/2022, 08/23/2022, 02/14/2022, 01/13/2022, and again 01/13/2022 have been considered by the examiner.
Withdrawn Objections and Rejections
The nonstatutory double patenting rejections of claims 21-22, 49, and 51 over the claims of copending Application No. 16,771,191 have been withdrawn, necessitated by amendments filed 12/02/2025.
The rejection of claims 1, 4, 7, and 21 under 35 U.S.C. 102 has been withdrawn, necessitated by amendments filed 12/02/2025.
The rejections of claims 22, 49, and 51 under 35 U.S.C. 103 have been withdrawn, necessitated by amendments filed 12/02/2025.
Status of Claims
Claims 1, 4, 7, 23, 25, 40-43, 45, 48, 50, 61, 80, 98 and 129-133 are pending and examined herein.
Claims 2-3, 5-6, 8-22, 24, 26-39, 44, 46-47, 49, 51-60, 62-79, 81-97, and 99-128 have been cancelled by the Applicant.
New and Modified Rejections
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, 4, 7, 23, 25, 40-42, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Funk (WO 2005042721 A2, published 2005-05-12, cited in PTO-892 dated 06/02/2025) in view of Lassalle et al. (“Human zona pellucida recognition associated with removal of sialic acid from human sperm surface”, published 1994, cited in PTO-892 dated 06/02/2025). These are modified rejections, necessitated by amendments filed 12/02/2025.
Funk teaches a method for separating X chromosome-bearing sperm cells and Y chromosome-bearing sperm cells with a sample sperm cell population, comprising: differentiating between sperm cells that have undergone capacitation and sperm cells that have not undergone said capacitation; and separating said sperm cells that have undergone said capacitation and said sperm cells that have not undergone said capacitation; wherein a majority of said sperm cells that have undergone said capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells; and wherein a majority of said sperm cells that have not undergone said capacitation comprise the other of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells, as in claim 1 (see, e.g., differentiating sperm cells that have undergone capacitation - Funk, page 3, lines 2-7; separating cells that have undergone capacitation – Funk, page 3, lines 11-15; wherein majority of sperm cells that have undergone capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells – Funk, page 3, lines 7-11).
Funk teaches that differentiating between sperm cells is facilitated by Y chromosome-bearing sperm cells undergoing capacitation more quickly than X chromosome-bearing sperm cells, as in claim 4 (see, e.g., Funk, page 5, lines 23-25).
Funk teaches inducing capacitation to produce a capacitation-induced sperm cell subpopulation in which said capacitation is induced in at least a portion of Y chromosome-bearing sperm cells, as in claim 7 (see, e.g., inducing capacitation - page 9, lines 6-12; at least a portion Y chromosome-bearing sperm cells – page 5, lines 23-24). The examiner understands the induction of capacitation to be equivalent to the promotion of capacitation because induce and promote are synonyms according to www.merriam-webster.com/thersarus/induce.
Funk fails to teach differentiating the X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells by employing saccharides as a capacitation indicator and binding a capacitation indicator associator, specifically a lectin, to the capacitation indicator and differentiating the sperm cells that have undergone the acrosome reaction from the sperm cells that have not undergone the acrosome reaction by employing an acrosome reaction indicator that associates with an acrosome reaction indicator associator, as in claims 1, 23, 25, and 40-42. However, in a journal article on change to the human sperm surface, Lassalle rectifies these deficiencies. Lassalle teaches saccharides as a capacitation indicator, as in claims 1 and 23 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 710, column 1, paragraph 2: “Capacitation is associated with the decrease in the net surface charge and loss of carbohydrates, including sialic acid”). Lassalle teaches lectins binding to saccharides on sperm, as in claim 25 (see, e.g., page 703, under Abstract). Lassalle discloses lectins are used to assess sperm acrosome reaction, as in claims 40-42 (see, e.g., page 707, column 1, paragraph 3).
Funk teaches inducing capacitation by incubating sperm in TALP (pH 7.4), which increases the external pH from a baseline external pH of at least 0.36 pH, as in claim 129 (see, e.g., p. 10, lines 14-17).
Funk and Lasselle are analogous to the field of the claimed invention because they are both in the field of mammalian fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the lectins of Lassalle to the method of Funk. The artisan would have been motivated to do so because Lasselle discloses that lectins can differentiate capacitated sperm cells from non-capacitated sperm cells and acrosome-reacted sperm cells from non-acrosome-reacted sperm cells while Funk disclosed, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). The combination of these disclosures would render obvious the method of differentiating X- and Y-bearing sperm cells from each other using lectins. An artisan would have had a reasonable expectation of success considering the given disclosures.
Funk does not explicitly state that the TALP buffer is increasing the external pH of the sample, as in claim 129. However, in page 5 of the instant specification, the Applicant discloses that “capacitation-inducing media which may be useful with the instant method can include Tyrode’s albumin lactate pyruvate (TALP) medium/buffer” (see, e.g., page 5, lines 13-14). Also, in the “Example” disclosed in the instant specification, the Applicant discloses that the baseline pH of the ejaculate was determined to be 5.93 (see, e.g., page 29, line 27). The Applicant further recites, “The sperm cell pellet was resuspended in sperm TALP buffer (BGM-1, pH 7.3)” (see, e.g., page 29, line 29). The pH of the buffer in Funk is higher than the pH of the buffer in the instant application example (pH 7.4 vs 7.3). The increase of pH to induce capacitation is an expected result based on the disclosure of Funk. An artisan would have had a reasonable expectation of success considering the given disclosures.
Claims 43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Funk (cited above) and Lassalle (cited above), as applied to claims 1, 4, 7, 23, 25, 40-42, and 129 above, and further in view of Manandhar (Gaurishankar Manandhar, Kiyotaka Toshimori, "Exposure of Sperm Head Equatorin after Acrosome Reaction and Its Fate after Fertilization in Mice", Biology of Reproduction, Volume 65, Issue 5, 1 November 2001, Pages 1425–1436, cited in PTO-892 dated 06/02/2025).
Funk and Lassalle teach as set forth above, but fail to teach equatorin as the acrosome reaction indicator and an equatorin antibody as the acrosome reaction indicator associator, as in claims 43 and 45. However, Manandhar rectifies this by teaching equatorin as the acrosome reaction indicator, as in claim 43 (see, e.g., page 1431, under “DISCUSSION”: “Equatorin is exposed after acrosome reaction that coincides with the functional maturity of the overlying equatorial plasma membrane to participate in fusion”). Manandhar teaches an antibody for equatorin, as in claim 45 (see, e.g., page 1425, column 2, paragraph 2).
Funk, Lassalle, and Manandhar are considered analogous to the claimed invention because they are in the same field of mammalian fertility. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use the antibody for the acrosome reaction indicator, equatorin, of Manandhar in the method of Funk and Lassalle. The artisan would have been motivated to do so because “equatorin contained in the posterior acrosome is detectable only after spontaneous or induced acrosome reactions” (see, e.g., Manandhar, page 1425, under “ABSTRACT”). This disclosure of equatorin as an acrosome reaction indicator and the antibody for equatorin would be useful to the artisan when differentiating and separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells because Funk also disclosed that, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). An artisan would have had a reasonable expectation of success considering the given disclosures.
Claims 48, 50, 61, 80, 98, and 130-133 are rejected under 35 U.S.C. 103 as being unpatentable over Funk and Lassalle, as applied to claims 1, 4, 7, 23, 25, 40-42, and 129 above, and further in view of Hudson (US 20090208977 A1, published 2009-08-20, cited in PTO-892 dated 06/02/2025).
Funk and Lassalle teach as set forth above. Funk and Lassalle also teach the separation of non-viable sperm cells and viable sperm cells, as in claim 98 (see, e.g., Funk, page 3, lines 11-15). Funk and Lassalle also teach the capacitation indicator comprises a saccharide and the capacitation indicator associator comprises a lectin that binds to the saccharide, as in claims 130-131 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 703, under Abstract). The examiner understands that dead populations of sperm cells are non-viable and alive populations of sperm cells would be viable. But, Funk and Lassalle fail to teach a method comprising separating sperm cells that have undergone capacitation from cells that have not by employing a magnetic particle associated with the capacitation indicator associator; wherein the magnetic particle is separable from the sample sperm cell population by the application of a magnetic force to which the particle is responsive, as in claim 48. Funk and Lassalle fail to teach applying the force to the sample sperm population, as in claim 50. Funk and Lassalle fail to teach the capacitation indicator associator is conjugated to the particle, as in claim 61. Funk and Lassalle fail to teach a second particle conjugated to an acrosome reaction indicator associator, wherein the particle is separable from the sample sperm cell population, as in claim 80. However, Hudson rectifies these deficiencies in a patent application publication entitled “MATERIALS AND METHODS FOR SPERM SEX SELECTION”. Hudson teaches a method for separating X- and Y-chromosome bearing sperm in a sperm sample comprising contacting the sample with specific binding agents on the surface of magnetic beads then separating the sperm cells bound to the binging agents from the unbound sperm cells by applying a magnetic force to the sample, as in claims 48, 50, 61, and 80 (see, e.g., Hudson, claims 1, 2, and 6). The examiner understands a binding agent to be equivalent to an associator and binding agents on the surface of magnetic particles to be equivalent to associator-particles.
Funk, Lassalle, and Hudson are analogous to the field of the claimed invention because they are all in the field of fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the associator-particles of Hudson into the methods of Funk and Lassalle. The artisan would have been motivated to do so because a binding agent, such as an antibody specifically binds to an antigen that is specific for an X- or Y- chromosome (see, e.g., Hudson, cover page, under “ABSTRACT”). Lassalle teaches lectins (a binding agent) as capacitation indicator associators as cited above. Furthermore, the use of the magnetic particles coated with a binding agent allows the sperm carrying the X-chromosome to be “easily separated by removing the supernatant from the vessel” (see, e.g., Hudson, page 5, column 2, paragraph [0044]).
In regards to claims 80 and 132-133, Hudson teaches the use of associator-particles for separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells and the use of a second associator immobilized on a substrate (see, e.g., Hudson, claims 6 and 7), but does not explicitly teach the use of two different associator-particles. However, in the instant case the number of different associator-particles and the order that they are used are clearly parameters that a person of ordinary skill in the art would routinely optimize (see MPEP § 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As noted in In re Aller, 105 USPQ 233 at 235, “More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Routine optimization is not considered inventive and no evidence has been presented that arriving at the steps of claims 80 and 132-133, i.e. adding a second associator-particle and using simultaneously or stepwise, was anything other than routine, that claims 80 and 132-133 resulting from optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious at the time of the instant invention. An artisan would have had a reasonable expectation of success considering the given disclosures.
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, 4, 7, 23, 25, 40-43, 45, 48, 50, 61, 80, 98, and 129-133 133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 21-23, 25, 40-43, 45, 48-51, 61, 80, 98, and 129 of copending Application No. 17/480,402 (referred to as ‘402 hereto).
With respect to claim 1, ‘402 teaches a method for separating X chromosome-bearing sperm cells and Y chromosome-bearing sperm cells within a sample sperm cell population, comprising: differentiating between sperm cells that have undergone capacitation and sperm cells that have not undergone said capacitation by: employing a capacitation indicator which is associated with capacitated sperm cells; and binding a capacitation indicator associator to said capacitation indicator; and separating said sperm cells that have undergone said capacitation and said sperm cells that have not undergone said capacitation; wherein a majority of said sperm cells that have undergone said capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells; and wherein a majority of said sperm cells that have not undergone said capacitation comprise the other of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells (see, e.g., claims 1 and 21-22).
With respect to claim 4, ‘402 teaches wherein said differentiating between sperm cells that have undergone said capacitation and sperm cells that have not undergone said capacitation is facilitated by said Y chromosome-bearing sperm cells undergoing said capacitation more quickly than said X chromosome-bearing sperm cells (see, e.g., claim 4 of ‘402).
With respect to claim 7, ‘402 teaches the method further comprising inducing said capacitation to generate a capacitation-induced sperm cell subpopulation in which said capacitation is induced in at least a portion of said Y chromosome-bearing sperm cells (see, e.g., claim 7 of ‘402).
With respect to claim 23, ‘402 teaches wherein said capacitation indicator comprises a saccharide (see, e.g., claim 23 of ‘402).
With respect to claim 25, ‘402 teaches wherein said capacitation indicator associator comprises a lectin which binds to said saccharide (see, e.g., claim 25 of ‘402).
With respect to claim 40, ‘402 teaches a method further comprising differentiating between sperm cells that have undergone the acrosome reaction and sperm cells that have not undergone said acrosome reaction; wherein said sperm cells that have undergone said acrosome reaction comprise acrosome-reacted sperm cells; and wherein said sperm cells that have not undergone said acrosome reaction comprise non- acrosome-reacted sperm cells (see, e.g., claim 40 of ‘402).
With respect to claim 41, ‘402 teaches a method further comprising employing an acrosome reaction indicator which is associated with said acrosome-reacted sperm cells to differentiate said acrosome-reacted sperm cells from said non-acrosome-reacted sperm cells (see, e.g., claim 41 of ‘402).
With respect to claim 42, ‘402 teaches a method furthering comprising associating an acrosome reaction indicator associator with said acrosome reaction indicator to differentiate said acrosome-reacted sperm cells from said non-acrosome-reacted sperm cells (see, e.g., claim 42 of ‘402).
With respect to claim 43, ‘402 teaches a method, wherein said acrosome reaction indicator comprises equatorin (see, e.g., claim 43 of ‘402).
With respect to claim 45, ‘402 teaches a method wherein said acrosome reaction indicator associator comprises an antibody which associates with said equatorin (see, e.g., claim 45 of ‘402).
With respect to claim 48, ‘402 teaches a method for separating X chromosome-bearing sperm cells and Y chromosome-bearing sperm cells within a sample sperm cell population, comprising: differentiating between sperm cells that have undergone capacitation and sperm cells that have not under one said capacitation; and separating said sperm cells that have under, one said capacitation and said sperm cells that have not undergone said capacitation by employing a magnetic first particle associated with a capacitation indicator associator which binds to a capacitation indicator; wherein said first particle is separable from said sample sperm cell population by the application of a magnetic force to which said first particle is responsive; wherein a majority of said sperm cells that have undergone said capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells; and wherein a majority of said sperm cells that have not undergone said capacitation comprise the other of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells (see, e.g., claims 1, 21-22, and 48-51).
With respect to claim 50, ‘402 teaches a method further comprising applying said force to said sample sperm cell population (see, e.g., claim 50 of ‘402).
With respect to claim 61, ‘402 teaches a method wherein said capacitation indicator associator is conjugated to said first particle to provide a capacitation indicator associator-particle (see, e.g., claim 48 of ‘402).
With respect to claim 80, ‘402 teaches a method further comprising a second particle associated with said acrosome reaction indicator associator, said second particle separable from said sample sperm cell population; wherein said acrosome reaction indicator associator is conjugated to said second particle to provide an acrosome reaction indicator associator-particle (see, e.g., claim 80 of ‘402).
With respect to claim 98, ‘402 teaches a method further comprising: differentiating between non-viable sperm cells and viable sperm cells; and separating said non-viable sperm cells and said viable sperm cells (see, e.g., claim 98 of ‘402).
With respect to claim 129, ‘402 teaches a method of claim 7, further comprising inducing said capacitation by increasing the external pH (pHe) (see, e.g., claim 129 of ‘402).
With respect to claim 130, ‘402 teaches a method wherein said capacitation indicator comprises a saccharide (see, e.g., claim 23 of ‘402).
With respect to claim 131, ‘402 teaches a method wherein said capacitation indicator associator comprises a lectin which binds to said saccharide (see, e.g., claim 25 of ‘402).
In regards to claims 129, ‘402 teaches inducing capacitation by increasing the external pH (see, e.g., claim 129 of ‘402), but does not explicitly teach the increase of pH is 0.36 pH units. However, in the instant case the increase of pH used is clearly a parameter that a person of ordinary skill in the art would routinely optimize (see MPEP § 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As noted in In re Aller, 105 USPQ 233 at 235, “More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Routine optimization is not considered inventive and no evidence has been presented that arriving at the steps of claim 129, i.e. using a pH increase of 0.36 pH units, was anything other than routine, that the properties of claim 129 resulting from optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious at the time of the instant invention. An artisan would have had a reasonable expectation of success considering the given disclosures.
In regards to claims 132-133, ‘402 teaches the use of first associator-particles for separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells and the use of second associator-particles (see, e.g., claims 48 and 80 of ‘402), but does not explicitly teach the order of the using the associator-particles. However, in the instant case the number of different associator-particles and the order that they are used are clearly parameters that a person of ordinary skill in the art would routinely optimize (see MPEP § 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As noted in In re Aller, 105 USPQ 233 at 235, “More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Routine optimization is not considered inventive and no evidence has been presented that arriving at the steps of claims 132-133, i.e. using two different associator-particles simultaneously or stepwise, was anything other than routine, that claims 132-133 resulting from optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious at the time of the instant invention. An artisan would have had a reasonable expectation of success considering the given disclosures.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1, 4, 7, 23, 25, 40-43, 45, 48, 50, 61, 80, 98, and 129-133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 16, and 25 of copending Application No. 16/771,191 (referred to as ‘191 hereto) in view of Funk (cited above), Lassalle (cited above), Manandhar (cited above), and Hudson (cited above).
‘191 teaches a method for separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells, as in claims 1 and 48 (see claim 1 of ‘191). ‘191 teaches the sperm cells are capacitated, as in claims 1 and 4 (see claim 5 of ‘191). ‘191 teaches the sperm cells comprise acrosome reacted cells, as in claim 42 (see claim 6 of ‘191). ‘191 teaches increasing the pH environment of sperm cells about 0.36, as in claim 129 (see claim 16 of ‘191). ‘191 teaches magnetically separating the separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells, as in claim 48 (see claim 25 of ‘191).
The deficiencies of ‘191 are rectified by the following disclosures. Funk teaches a method for separating X chromosome-bearing sperm cells and Y chromosome-bearing sperm cells with a sample sperm cell population, comprising: differentiating between sperm cells that have undergone capacitation and sperm cells that have not undergone said capacitation; and separating said sperm cells that have undergone said capacitation and said sperm cells that have not undergone said capacitation; wherein a majority of said sperm cells that have undergone said capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells; and wherein a majority of said sperm cells that have not undergone said capacitation comprise the other of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells, as in claim 1 (see, e.g., differentiating sperm cells that have undergone capacitation - Funk, page 3, lines 2-7; separating cells that have undergone capacitation – Funk, page 3, lines 11-15; wherein majority of sperm cells that have undergone capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells – Funk, page 3, lines 7-11).
Funk teaches that differentiating between sperm cells is facilitated by Y chromosome-bearing sperm cells undergoing capacitation more quickly than X chromosome-bearing sperm cells, as in claim 4 (see, e.g., Funk, page 5, lines 23-25).
Funk teaches inducing capacitation to produce a capacitation-induced sperm cell subpopulation in which said capacitation is induced in at least a portion of Y chromosome-bearing sperm cells, as in claim 7 (see, e.g., inducing capacitation - page 9, lines 6-12; at least a portion Y chromosome-bearing sperm cells – page 5, lines 23-24). The examiner understands the induction of capacitation to be equivalent to the promotion of capacitation because induce and promote are synonyms according to www.merriam-webster.com/thersarus/induce.
Funk and ‘191 fail to teach differentiating the X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells by employing saccharides as a capacitation indicator and binding a capacitation indicator associator, specifically a lectin, to the capacitation indicator and differentiating the sperm cells that have undergone the acrosome reaction from the sperm cells that have not undergone the acrosome reaction by employing an acrosome reaction indicator that associates with an acrosome reaction indicator associator, as in claims 1, 23, 25, and 40-42. However, in a journal article on change to the human sperm surface, Lassalle rectifies these deficiencies. Lassalle teaches saccharides as a capacitation indicator, as in claims 1 and 23 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 710, column 1, paragraph 2: “Capacitation is associated with the decrease in the net surface charge and loss of carbohydrates, including sialic acid”). Lassalle teaches lectins binding to saccharides on sperm, as in claim 25 (see, e.g., page 703, under Abstract). Lassalle discloses lectins are used to assess sperm acrosome reaction, as in claims 40-42 (see, e.g., page 707, column 1, paragraph 3).
Funk teaches inducing capacitation by incubating sperm in TALP (pH 7.4), which increases the external pH from a baseline external pH of at least 0.36 pH, as in claim 129 (see, e.g., p. 10, lines 14-17).
‘191, Funk, and Lasselle are analogous to the field of the claimed invention because they are both in the field of mammalian fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the lectins of Lassalle to the method of Funk. The artisan would have been motivated to do so because Lasselle discloses that lectins can differentiate capacitated sperm cells from non-capacitated sperm cells and acrosome-reacted sperm cells from non-acrosome-reacted sperm cells while Funk disclosed, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). The combination of these disclosures would render obvious the method of differentiating X- and Y-bearing sperm cells from each other using lectins. An artisan would have had a reasonable expectation of success considering the given disclosures.
Funk does not explicitly state that the TALP buffer is increasing the external pH of the sample, as in claim 129. However, in page 5 of the instant specification, the Applicant discloses that “capacitation-inducing media which may be useful with the instant method can include Tyrode’s albumin lactate pyruvate (TALP) medium/buffer” (see, e.g., page 5, lines 13-14). Also, in the “Example” disclosed in the instant specification, the Applicant discloses that the baseline pH of the ejaculate was determined to be 5.93 (see, e.g., page 29, line 27). The Applicant further recites, “The sperm cell pellet was resuspended in sperm TALP buffer (BGM-1, pH 7.3)” (see, e.g., page 29, line 29). The pH of the buffer in Funk is higher than the pH of the buffer in the instant application example (pH 7.4 vs 7.3). The increase of pH to induce capacitation is an expected result based on the disclosure of Funk. An artisan would have had a reasonable expectation of success considering the given disclosures.
‘191, Funk, and Lassalle teach as set forth above, but fail to teach equatorin as the acrosome reaction indicator and an equatorin antibody as the acrosome reaction indicator associator, as in claims 43 and 45. However, Manandhar rectifies this by teaching equatorin as the acrosome reaction indicator, as in claim 43 (see, e.g., page 1431, under “DISCUSSION”: “Equatorin is exposed after acrosome reaction that coincides with the functional maturity of the overlying equatorial plasma membrane to participate in fusion”). Manandhar teaches an antibody for equatorin, as in claim 45 (see, e.g., page 1425, column 2, paragraph 2).
‘191, Funk, Lassalle, and Manandhar are considered analogous to the claimed invention because they are in the same field of mammalian fertility. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use the antibody for the acrosome reaction indicator, equatorin, of Manandhar in the method of Funk and Lassalle. The artisan would have been motivated to do so because “equatorin contained in the posterior acrosome is detectable only after spontaneous or induced acrosome reactions” (see, e.g., Manandhar, page 1425, under “ABSTRACT”). This disclosure of equatorin as an acrosome reaction indicator and the antibody for equatorin would be useful to the artisan when differentiating and separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells because Funk also disclosed that, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). An artisan would have had a reasonable expectation of success considering the given disclosures.
‘191, Funk, and Lassalle teach as set forth above. Funk and Lassalle also teach the separation of non-viable sperm cells and viable sperm cells, as in claim 98 (see, e.g., Funk, page 3, lines 11-15). Funk and Lassalle also teach the capacitation indicator comprises a saccharide and the capacitation indicator associator comprises a lectin that binds to the saccharide, as in claims 130-131 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 703, under Abstract). The examiner understands that dead populations of sperm cells are non-viable and alive populations of sperm cells would be viable. But, Funk and Lassalle fail to teach a method comprising separating sperm cells that have undergone capacitation from cells that have not by employing a magnetic particle associated with the capacitation indicator associator; wherein the magnetic particle is separable from the sample sperm cell population by the application of a magnetic force to which the particle is responsive, as in claim 48. Funk and Lassalle fail to teach applying the force to the sample sperm population, as in claim 50. Funk and Lassalle fail to teach the capacitation indicator associator is conjugated to the particle, as in claim 61. Funk and Lassalle fail to teach a second particle conjugated to an acrosome reaction indicator associator, wherein the particle is separable from the sample sperm cell population, as in claim 80. However, Hudson rectifies these deficiencies in a patent application publication entitled “MATERIALS AND METHODS FOR SPERM SEX SELECTION”. Hudson teaches a method for separating X- and Y-chromosome bearing sperm in a sperm sample comprising contacting the sample with specific binding agents on the surface of magnetic beads then separating the sperm cells bound to the binging agents from the unbound sperm cells by applying a magnetic force to the sample, as in claims 48, 50, 61, and 80 (see, e.g., Hudson, claims 1, 2, and 6). The examiner understands a binding agent to be equivalent to an associator and binding agents on the surface of magnetic particles to be equivalent to associator-particles.
Funk, Lassalle, and Hudson are analogous to the field of the claimed invention because they are all in the field of fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the associator-particles of Hudson into the methods of Funk and Lassalle. The artisan would have been motivated to do so because a binding agent, such as an antibody specifically binds to an antigen that is specific for an X- or Y- chromosome (see, e.g., Hudson, cover page, under “ABSTRACT”). Lassalle teaches lectins (a binding agent) as capacitation indicator associators as cited above. Furthermore, the use of the magnetic particles coated with a binding agent allows the sperm carrying the X-chromosome to be “easily separated by removing the supernatant from the vessel” (see, e.g., Hudson, page 5, column 2, paragraph [0044]).
In regards to claims 80 and 132-133, Hudson teaches the use of associator-particles for separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells and the use of a second associator immobilized on a substrate (see, e.g., Hudson, claims 6 and 7), but does not explicitly teach the use of two different associator-particles. However, in the instant case the number of different associator-particles and the order that they are used are clearly parameters that a person of ordinary skill in the art would routinely optimize (see MPEP § 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As noted in In re Aller, 105 USPQ 233 at 235, “More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Routine optimization is not considered inventive and no evidence has been presented that arriving at the steps of claims 80 and 132-133, i.e. adding a second associator-particle and using simultaneously or stepwise, was anything other than routine, that claims 80 and 132-133 resulting from optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious at the time of the instant invention. An artisan would have had a reasonable expectation of success considering the given disclosures.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 7, 23, 25, 40-43, 45, 48, 50, 61, 80, 98, and 129-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7 of U.S. Patent No. 11531026 (referred to as ‘026 hereto) in view of Funk (cited above), Lassalle (cited above), Manandhar (cited above), and Hudson (cited above).
‘026 teaches a method for separating sperm cells with particles based on subpopulation indicators, as in claims 1 and 48 (see claim 1 of ‘026). ‘026 teaches the sperm cells are capacitated, as in claims 1 and 4 (see claim 7 of ‘026). ‘026 teaches magnetically separating the separating sperm cells from Y chromosome-bearing sperm cells, as in claim 48 (see claim 4 of ‘026).
The deficiencies of ‘026 are rectified by the following disclosures. Funk teaches a method for separating X chromosome-bearing sperm cells and Y chromosome-bearing sperm cells with a sample sperm cell population, comprising: differentiating between sperm cells that have undergone capacitation and sperm cells that have not undergone said capacitation; and separating said sperm cells that have undergone said capacitation and said sperm cells that have not undergone said capacitation; wherein a majority of said sperm cells that have undergone said capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells; and wherein a majority of said sperm cells that have not undergone said capacitation comprise the other of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells, as in claim 1 (see, e.g., differentiating sperm cells that have undergone capacitation - Funk, page 3, lines 2-7; separating cells that have undergone capacitation – Funk, page 3, lines 11-15; wherein majority of sperm cells that have undergone capacitation comprise one of said X chromosome-bearing sperm cells or said Y chromosome-bearing sperm cells – Funk, page 3, lines 7-11).
Funk teaches that differentiating between sperm cells is facilitated by Y chromosome-bearing sperm cells undergoing capacitation more quickly than X chromosome-bearing sperm cells, as in claim 4 (see, e.g., Funk, page 5, lines 23-25).
Funk teaches inducing capacitation to produce a capacitation-induced sperm cell subpopulation in which said capacitation is induced in at least a portion of Y chromosome-bearing sperm cells, as in claim 7 (see, e.g., inducing capacitation - page 9, lines 6-12; at least a portion Y chromosome-bearing sperm cells – page 5, lines 23-24). The examiner understands the induction of capacitation to be equivalent to the promotion of capacitation because induce and promote are synonyms according to www.merriam-webster.com/thersarus/induce.
Funk and ‘026 fail to teach differentiating the X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells by employing saccharides as a capacitation indicator and binding a capacitation indicator associator, specifically a lectin, to the capacitation indicator and differentiating the sperm cells that have undergone the acrosome reaction from the sperm cells that have not undergone the acrosome reaction by employing an acrosome reaction indicator that associates with an acrosome reaction indicator associator, as in claims 1, 23, 25, and 40-42. However, in a journal article on change to the human sperm surface, Lassalle rectifies these deficiencies. Lassalle teaches saccharides as a capacitation indicator, as in claims 1 and 23 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 710, column 1, paragraph 2: “Capacitation is associated with the decrease in the net surface charge and loss of carbohydrates, including sialic acid”). Lassalle teaches lectins binding to saccharides on sperm, as in claim 25 (see, e.g., page 703, under Abstract). Lassalle discloses lectins are used to assess sperm acrosome reaction, as in claims 40-42 (see, e.g., page 707, column 1, paragraph 3).
Funk teaches inducing capacitation by incubating sperm in TALP (pH 7.4), which increases the external pH from a baseline external pH of at least 0.36 pH, as in claim 129 (see, e.g., p. 10, lines 14-17).
‘026, Funk, and Lasselle are analogous to the field of the claimed invention because they are both in the field of mammalian fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the lectins of Lassalle to the method of Funk. The artisan would have been motivated to do so because Lasselle discloses that lectins can differentiate capacitated sperm cells from non-capacitated sperm cells and acrosome-reacted sperm cells from non-acrosome-reacted sperm cells while Funk disclosed, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). The combination of these disclosures would render obvious the method of differentiating X- and Y-bearing sperm cells from each other using lectins. An artisan would have had a reasonable expectation of success considering the given disclosures.
Funk does not explicitly state that the TALP buffer is increasing the external pH of the sample, as in claim 129. However, in page 5 of the instant specification, the Applicant discloses that “capacitation-inducing media which may be useful with the instant method can include Tyrode’s albumin lactate pyruvate (TALP) medium/buffer” (see, e.g., page 5, lines 13-14). Also, in the “Example” disclosed in the instant specification, the Applicant discloses that the baseline pH of the ejaculate was determined to be 5.93 (see, e.g., page 29, line 27). The Applicant further recites, “The sperm cell pellet was resuspended in sperm TALP buffer (BGM-1, pH 7.3)” (see, e.g., page 29, line 29). The pH of the buffer in Funk is higher than the pH of the buffer in the instant application example (pH 7.4 vs 7.3). The increase of pH to induce capacitation is an expected result based on the disclosure of Funk. An artisan would have had a reasonable expectation of success considering the given disclosures.
‘026, Funk, and Lassalle teach as set forth above, but fail to teach equatorin as the acrosome reaction indicator and an equatorin antibody as the acrosome reaction indicator associator, as in claims 43 and 45. However, Manandhar rectifies this by teaching equatorin as the acrosome reaction indicator, as in claim 43 (see, e.g., page 1431, under “DISCUSSION”: “Equatorin is exposed after acrosome reaction that coincides with the functional maturity of the overlying equatorial plasma membrane to participate in fusion”). Manandhar teaches an antibody for equatorin, as in claim 45 (see, e.g., page 1425, column 2, paragraph 2).
‘026, Funk, Lassalle, and Manandhar are considered analogous to the claimed invention because they are in the same field of mammalian fertility. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use the antibody for the acrosome reaction indicator, equatorin, of Manandhar in the method of Funk and Lassalle. The artisan would have been motivated to do so because “equatorin contained in the posterior acrosome is detectable only after spontaneous or induced acrosome reactions” (see, e.g., Manandhar, page 1425, under “ABSTRACT”). This disclosure of equatorin as an acrosome reaction indicator and the antibody for equatorin would be useful to the artisan when differentiating and separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells because Funk also disclosed that, “As X- and Y-bearing sperm age, they undergo various process[sic], such as capacitation and the acrosome reaction at different rates” (see, e.g., Funk, page 3, lines 5-7). An artisan would have had a reasonable expectation of success considering the given disclosures.
‘026, Funk, and Lassalle teach as set forth above. Funk and Lassalle also teach the separation of non-viable sperm cells and viable sperm cells, as in claim 98 (see, e.g., Funk, page 3, lines 11-15). Funk and Lassalle also teach the capacitation indicator comprises a saccharide and the capacitation indicator associator comprises a lectin that binds to the saccharide, as in claims 130-131 (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added, and page 703, under Abstract). The examiner understands that dead populations of sperm cells are non-viable and alive populations of sperm cells would be viable. But, Funk and Lassalle fail to teach a method comprising separating sperm cells that have undergone capacitation from cells that have not by employing a magnetic particle associated with the capacitation indicator associator; wherein the magnetic particle is separable from the sample sperm cell population by the application of a magnetic force to which the particle is responsive, as in claim 48. Funk and Lassalle fail to teach applying the force to the sample sperm population, as in claim 50. Funk and Lassalle fail to teach the capacitation indicator associator is conjugated to the particle, as in claim 61. Funk and Lassalle fail to teach a second particle conjugated to an acrosome reaction indicator associator, wherein the particle is separable from the sample sperm cell population, as in claim 80. However, Hudson rectifies these deficiencies in a patent application publication entitled “MATERIALS AND METHODS FOR SPERM SEX SELECTION”. Hudson teaches a method for separating X- and Y-chromosome bearing sperm in a sperm sample comprising contacting the sample with specific binding agents on the surface of magnetic beads then separating the sperm cells bound to the binging agents from the unbound sperm cells by applying a magnetic force to the sample, as in claims 48, 50, 61, and 80 (see, e.g., Hudson, claims 1, 2, and 6). The examiner understands a binding agent to be equivalent to an associator and binding agents on the surface of magnetic particles to be equivalent to associator-particles.
Funk, Lassalle, and Hudson are analogous to the field of the claimed invention because they are all in the field of fertility. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the associator-particles of Hudson into the methods of Funk and Lassalle. The artisan would have been motivated to do so because a binding agent, such as an antibody specifically binds to an antigen that is specific for an X- or Y- chromosome (see, e.g., Hudson, cover page, under “ABSTRACT”). Lassalle teaches lectins (a binding agent) as capacitation indicator associators as cited above. Furthermore, the use of the magnetic particles coated with a binding agent allows the sperm carrying the X-chromosome to be “easily separated by removing the supernatant from the vessel” (see, e.g., Hudson, page 5, column 2, paragraph [0044]).
In regards to claims 80 and 132-133, Hudson teaches the use of associator-particles for separating X chromosome-bearing sperm cells from Y chromosome-bearing sperm cells and the use of a second associator immobilized on a substrate (see, e.g., Hudson, claims 6 and 7), but does not explicitly teach the use of two different associator-particles. However, in the instant case the number of different associator-particles and the order that they are used are clearly parameters that a person of ordinary skill in the art would routinely optimize (see MPEP § 2144.05). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As noted in In re Aller, 105 USPQ 233 at 235, “More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Routine optimization is not considered inventive and no evidence has been presented that arriving at the steps of claims 80 and 132-133, i.e. adding a second associator-particle and using simultaneously or stepwise, was anything other than routine, that claims 80 and 132-133 resulting from optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious at the time of the instant invention. An artisan would have had a reasonable expectation of success considering the given disclosures.
Response to Arguments
Double Patenting Rejection
The examiner acknowledges the Applicant’s stated intent to cancel or maintain a clear line of demarcation between the claims of Unites States Patent Application No. 17/480,402 and the claims of the instant application. However, at this time, the claims of Application No. 17/480,402 are pending and are patentably indistinct from the claims of the instant application. Therefore, the double patenting rejection of instant claims 1, 4, 7, 23, 25, 40-43, 45, 48, 50, 61, 80, 98, and 129-133 is maintained.
35 U.S.C. 102 Rejection
The rejection of claims 1, 4, 7, and 21 as being anticipated by Funk (cited above) have been withdrawn, necessitated by amendments filed 12/02/2025, rendering the applicant’s arguments moot. New prior art rejections incorporating the amended limitations of claims 1, 4, and 7 are discussed above.
35 U.S.C. 103 Rejections
The applicant’s arguments that Funk in view of Lassalle do not teach all of the limitations of the original claim 22 which is now incorporated into currently amended independent claim 1 are not found persuasive. The amendments to claim 1 necessitated new grounds of rejection, as discussed above. In the new grounds of rejection, the Office clearly demonstrates that Lassalle teaches a capacitation indicator which is associated with capacitated sperm cells to which a capacitation indicator associator binds (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added). Therefore, Funk and Lassalle teach each element claimed in original claim 22 now incorporated into currently amended independent claim 1.
The applicant’s arguments regarding original claim 23 are based on the same fact-pattern regarding original claim 22. Therefore, the Office’s response above holds true for these arguments.
On page 13, the applicant recites arguments regarding the 35 U.S.C. 103 rejection of claim 25:
PNG
media_image1.png
544
854
media_image1.png
Greyscale
PNG
media_image2.png
372
850
media_image2.png
Greyscale
Emphasis added.
The applicant’s arguments are not found persuasive. The amendments to independent claim 1 necessitated new grounds of rejection, as discussed above. In the new grounds of rejection, the Office clearly demonstrates that Lassalle teaches a capacitation indicator which is associated with capacitated sperm cells to which a capacitation indicator associator, specifically a lectin, binds (see, e.g., page 707, column 1, paragraph 3: “Preliminary studies in which incubation was for 24 h at 4°C showed that percentages of acrosome-reacted spermatozoa assessed by PNA-FITC or Con A—FITC, two lectins used to assess sperm acrosome reaction (Mortimer et al, 1987; Holden et al, 1990), were higher ( < 0.05) for capacited [sic] (39.3%) than for untreated spermatozoa (15.1%)” Emphasis added). Therefore, Funk and Lassalle teach each element claimed in claim 25.
On page 14-15, the applicant recites arguments regarding the 35 U.S.C. 103 rejection of claim 48:
PNG
media_image3.png
93
876
media_image3.png
Greyscale
PNG
media_image3.png
93
876
media_image3.png
Greyscale
PNG
media_image4.png
370
850
media_image4.png
Greyscale
PNG
media_image5.png
544
862
media_image5.png
Greyscale
Underline emphasis added.
The applicant’s arguments are not found persuasive. Firstly, Funk’s disclosure that their invention does not require physical or mechanical sorting is not a teaching away. “[T]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (“a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.”) (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023). Funk’s disclosure shows that physical or mechanical sorting is not required, but the disclosure does not discourage an artisan from physical or mechanical sorting. In fact, Funk discloses, “When it is desired to separate distinct X and Y rich fractions, various methods may be used, including separation based on differential sugar affinities expressed by capacitated, acrosome reacted spermatozoa and non-capacitated sperm, Sephadex™ and glass wool filtering, or Optiprep™ and other centrifugation gradients to separate live and dead populations” (see, p. 3, lines 11-15). Funk expresses that their invention is compatible with the separation of distinct X and Y rich fractions, including by saccharide expression by capacitated- and acrosome-reacted sperm.
Additionally, Funks disclosure of magnetic techniques for separating X- and Y-bearing chromosomes is not a teaching away. Funk continues by stating that no successful method has been devised for differentiating spermatozoa based on a qualitative measure. Because “qualitative measure” is not defined by Funk, it is unclear what that statement is referring to. Nevertheless, an artisan would understand that Funk discloses magnetic techniques for separating X- and Y-bearing chromosome and discloses that their method is compatible with such separation techniques. An artisan would not reasonably be discouraged from combining Funk’s methods with a magnetic separation technique.
Thirdly, an artisan, upon reading the review of Seidel and Garner, would not have been discouraged from using magnetic separation techniques with the methods of Funk. Seidel and Garner’s disclosure in 2002 that they are unaware of any practical spermatozoa sex-sorting methods besides flow cytometry and cell sorting for producing viable spermatozoa would not have discouraged an artisan from combining the methods of Funk with magnetic separation techniques at the time of the instant application’s filing. An artisan would have understood that technological advances in the decades since Seidel and Garner’s review would lead to improvements in spermatozoa sex-sorting techniques. The artisan would have also known that Funk explicitly states that their methods can be combined with separation techniques. Therefore, for all these reasons, Funk does not teach away from using their invention with separation or sorting.
On page 15-16, the applicant argues that the arguments made regarding independent claims 1 and 48 render dependent claims 50, 61, 80, 98, and 129 novel and nonobvious. However, the applicant’s arguments regarding independent claims 1 and 48 are not found persuasive, as discussed above, therefore, dependent claims 50, 61, 80, 98, and 129 remain rejected.
Conclusion
No claims are allowed.
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 MICHAEL C SVEIVEN whose telephone number is (703)756-4653. The examiner can normally be reached Monday to Friday - 8AM to 5PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678