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 .
DETAILED ACTION
Preliminary Amendment
1. Applicant's preliminary amendment filed March 10, 2023 is acknowledged and has been entered. Claims 1-57 have been cancelled. Claims 58-77 have been added. Accordingly, claims 58-77 are pending and are under examination.
Priority
2. Applicant’s claim for the benefit of prior-filed applications under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a continuation of U.S. Patent Application Serial Number (ASN) 16/537,402 filed 08/09/2019, which is a continuation of ASN 14/960,096 filed 12/04/2015 which claims the benefit of Provisional Application Number 62/088,425 filed 12/05/2014. ASN 16/537,402 filed 08/09/2019 is also a continuation-in-part (CIP) 13/974,139 filed 08/23/2013 which claims the benefit of Provisional Application Number 61/694,756 filed 08/29/2012. Based on the Filing Receipt, the effective filing date of the instant application having the claimed subject matter in claims 58-61, 70, and 77 is August 29, 2012 which is the filing date of Provisional Application Number 61/694,756 from which the benefit of priority is claimed. Based on the Filing Receipt, the effective filing date of the instant application having the claimed subject matter in claims 62-69 and 71-76 is December 5, 2014 which is the filing date of Provisional Application Number 62/088,425 from which the benefit of priority is claimed.
3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed CIP ASN 13/974,139 fails to provide adequate written description support or enablement in the manner provided by 35 USC § 112(a) for one or more claims of this application. In this case, ASN 13/974,139 fails to provide adequate description of the subject matter describing “forming a composition comprising sperm and magnetic particles; wherein the composition has a pH of 6.5 or higher recited in dependent claims 62-69 and wherein the composition has sperm cell concentrations of 500 x 106 cells/ml or less recited in dependent claims 71-76. As the subject matter is only disclosed in Provisional Application Number 62/088,425, claims 62-69 and 71-76 are deemed to have the effective filing date of December 5, 2014 which is the filing date of Provisional Application Number 62/088,425 from which the benefit of priority is claimed.
Application Data Sheet
4. A reference to the prior application ASN 16/537,402, filed 08/09/2019 has been indicated in an application data sheet (37 CFR 1.76), under 35 U.S.C. 119(e), 120, 121, or 365(c). See 37 CFR 1.78(a). However, the current status of parent ASN 16/537,402, i.e. US Patent Number, is missing.
Trademark Usage
5. The use of the terms “IVF”, “AI”, “ICSI”, “MOET” in page 3; “Tris”, “HEPES”, “Fura-2”, “IDA” etc. in page 6; “Hoechst 33342”, “SYBR-14” etc. in page 11 which appear to be trade names or trademarks used in commerce, and all occurrences of trade names in the specification has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Specification
6. The disclosure is objected to because of the following informalities:
In the Brief Description of the Drawings:
Figure 10 and Figure 11 have not been differentially described.
Figure 12, Figure 13, and Figure 14 have not been differentially described.
Figure 15 and Figure 16 have not been differentially described.
Figure 17 and Figure 18 have not been differentially described.
Figure 20, Figure 21, and Figure 22 have not been differentially described.
Figure 26 and Figure 27 have not been differentially described.
Figure 29 and Figure 30 have not been differentially described.
Figure 29 and Figure 30 have not been differentially described.
Figure 31 and Figure 32 have not been differentially described.
Figure 33 and Figure 34 have not been differentially described.
Figure 35 and Figure 36 have not been differentially described.
Figure 37 and Figure 41 have not been differentially described.
Figure 38, Figure 39, and Figure 40 have not been differentially described.
Appropriate correction is required.
Information Disclosure Statement
7. The information disclosure statement filed March 10, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. In this case, neither a copy nor statement of relevancy has been provided for Reference Number 22. It has been placed in the application file, but the information referred to therein has not been considered.
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.
8. Claim 58-77 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.
Claim 58 in line 2 is vague and indefinite in reciting, “forming a composition comprising sperm cells and magnetic particles” because it is unclear what active laboratory step is encompassed in the term “forming.” As recited, “forming” is a subjective term lacking a comparative basis for defining its metes and bounds. Does Applicant intend “contacting” or “combining” sperm cells with magnetic particles to form complexes between …?
Claim 58 in lines 2-3 is ambiguous in reciting, “the magnetic particles forming complexes with a portion of the sperm cells” because it fails to clearly define what is encompassed in the term “portion” with respect to the sperm cells . As recited, “portion” is a relative term that is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what “portion” of the sperm cells forms complexes with the magnetic particles.
Claim 58 in line 3 is indefinite in reciting an open-ended numerical range in reciting “the magnetic particles being less than 1000 nm in size” because “less than 1000 nm” appears to encompass “0 nm” which then apparently imparts the exclusion of any magnetic particles in the claim.
Claim 58 in line 6 is further vague and indefinite in reciting “applying a magnetic field to the composition;” because it fails to clearly define how the magnetic field is applied in the claimed method in a manner that processes the sperm cells relative to the magnetic particles and the formed complexes through electrical charge interaction. Does Applicant intend for the formed complexes to be separated from unbound sperm cells and/or unbound components?
Claim 60 is ambiguous in relation to claim 59 from which it depends in reciting, “the outer layer comprising a chargeable, or charged, moiety” which is recited as “comprising a metal, an oxide, …” in claim 61 because it fails to clearly define how the “chargeable or charged, moiety” is structured or configured relative to the “polysaccharide, alkylsilane, polylactic acid, etc” in claim 59 which also comprises the outer layer of the magnetic particles. See also claim 61.
Claim 62 is indefinite in reciting, “pH of 6.5 or higher” because it recites an open-ended numerical range of alkalinity. Additionally, “higher” is a relative term that is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Same analogous comments and problems in claim 62 applies to claims 63-69.
Claim 71 is indefinite in reciting an open-ended numerical range in reciting “sperm cells at a concentration of 500 x 106 cells/ml or less” because “or less cells/ml” appears to encompass “0 cells/ml” which then apparently imparts the exclusion of any sperm cells in the claim. Additionally, “less” is a relative term that is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Same analogous comments and problems in claim 71 applies to claims 72-76.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,630,108. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells comprising forming a composition which comprises a mixture of sperm cells and magnetic particles by contacting or combining the sperm cells and the magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. less than 1000 nm) and a negative zeta potential charge to thereby form a composition; wherein the magnetic particles form complexes with compromised or damaged or dead (photodamaged / ablated) sperm cells through electrical interaction; and applying magnetic field to the formed composition to thus separate the magnetic-particle-bound dead or damaged sperm cells from unbound sperm cells. The composition has a pH of 6.5 to 8.0 with sperm cells having a concentration of 120 x 106 cells/ml to 500 x 106 cells/ml. The magnetic particles comprise chargeable or charged moiety such as a carboxylate group.
10. Claims 58-61, 70, and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11 and 17-25 of U.S. Patent No. 10,379,026. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells comprising forming a composition which comprises a mixture of sperm cells and magnetic particles by contacting or combining the sperm cells and the magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. less than 1000 nm) and a negative zeta potential charge to thereby form a composition; wherein the magnetic particles form complexes with compromised or damaged or dead sperm cells through electrical interaction; and applying magnetic field to the formed composition to thus separate the magnetic particle-bound dead or damaged sperm cells from unbound sperm cells. The composition has a pH of 6.5 to 8.0 with sperm cells having a concentration of 120 x 106 cells/ml to 500 x 106 cells/ml. The magnetic particles comprise chargeable or charged moiety such as a carboxylate group.
11. Claims 58-61, 70, and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,804,153. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells by separating viable sperm cells from dead or damaged sperm cells comprising contacting the sperm cells with the magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. no greater than 1000 nm) and a magnetic substrate coated with a chargeable silicon-containing compound to effect a negative zeta potential charge; wherein the magnetic particles bind to damaged or dead sperm cells through electrical interaction; and applying magnetic field to the mixture to thus separate the magnetic particle-bound dead or damaged sperm cells from unbound viable sperm cells.
12. Claims 58-61, 70 and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 10,324,086. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells by separating viable sperm cells from dead or damaged sperm cells comprising forming a composition which comprises a mixture of sperm cells, buffer, and magnetic particles by contacting binding the sperm cells to the magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. no greater than 1000 nm) and coated with a chargeable silicon containing compound to effect a negative zeta potential charge to thereby form a composition; wherein the magnetic particles bind to and form complexes with damaged or dead sperm cells through electrical interaction; and applying magnetic field to the formed composition to magnetically separate the magnetic particle-bound dead or damaged sperm cells from unbound viable sperm cells.
13. Claims 58-61, 70, and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,531,026. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells comprising combining the sperm cells with magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. less than 1000 nm), a negative zeta potential charge, and a charged surface via coating with a chargeable silicon-containing compound; wherein the magnetic particles bind to and form complexes with sperm cells having a positive zeta potential charge through electrical charge interaction to form magnetic particle bound sperm cells; and applying magnetic field to magnetically separate the magnetic particle-bound sperm cells from unbound sperm cells.
14. Claims 58-61, 70, and 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,662,344. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a method of processing sperm cells comprising contacting the sperm cells with a plurality of magnetic particles having a diameter (size) of 30 - 1000 nm (i.e. less than 1000 nm), a negative zeta potential charge, and coated with a chargeable silicon-containing compound; wherein the magnetic particles bind to and form complexes with sperm cells having a positive zeta potential through electrical interaction to form magnetic particle bound cells; and applying magnetic field to the magnetic particle bound sperm cells to thus separate the magnetic particle-bound sperm cells from unbound sperm cells.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
15. Claims 58-61 and 70-77 are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al. (US 2012/0270204) in view of Reutelingsperger et al. (Annexin V, the regulator of phosphatidylserine-catalyzed inflammation and coagulation during apoptosis. CMLS: Cell Mol. Life Sci. 53: 527-532 (1997)).
Fox et al. disclose a method of processing a sperm cells comprising combining sperm cells with magnetic particles having a diameter (size) of less than 1000 nm (10-800 nm) to thus form a composition and applying a magnetic field to the formed composition. The magnetic particles are non-toxic to the sperm cells and comprise carboxyl groups (carboxyl group functionalized magnetic particles) including amine, amide, oxide groups. The magnetic particles specifically have an outer layer which comprises polysaccharides, alkylsilanes, polylactic acids (PLA), polycaprolactone (PCL), polyhydroxybutyrate-valerate (PHBV) or polyolefin such as polyethylene (Abstract; [0005, 0007, 0008, 0011, 0015, 0019, 0027, 0029, 0033-0038, 0157]; Example 2). The formed composition comprises a buffer (nutrient-rich buffers) [0021, 0034-0038]. The sperm cells have a concentration of 5 x 106 cells/ml (i.e. encompassing 500 x 106 cells/ml or less in claim 71; 400 x 106 cells/ml or less in claim 72; 300 x 106 cells/ml or less in claim 73; 3200 x 106 cells/ml or less in claim 74; 180 x 106 cells/ml in claim 75; and 120 x 106 cells/ml in claim 76).
With respect to the recitation of the composition as “comprising a negative zeta potential,” Fox et al. teach that the magnetic particles may be conjugated with Annexin-V for binding with phosphatidylserine (PS) externalized to the outer layer of apoptotic cells including dead or damaged sperm cells so as to be used in determining the electric charge of the composition [0013-0018, 0024].
Fox et al. is silent in teaching that the composition comprising sperm cells and magnetic particles have a negative zeta potential charge.
Reutelingsperger et al. teach that phospholipids such as phosphatidylserine (PS) which are externalized to the outer layer of apoptotic cells (i.e. dead or damaged sperm cells) during apoptosis are inherently negatively charged and, therefore, comprise negative zeta potential (Abstract). According to Reutelingsperger et al., binding through electrical charge interaction is inherent to PS-Annexin V binding, as in the method of Fox et al. (Abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have incorporated the teaching of Reutelingsperger that PS which is externalized in apoptotic cells has a negative zeta potential, into the method of processing and separating apoptotic sperm cells as taught by Fox because Fox specifically taught binding Annexin V conjugated with magnetic particles to PS on apoptotic cells so as to magnetically separate apoptotic sperm cells, PS being inherently known to be negatively charged.
16. Claims 62-69 are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al. (US 2012/0270204) in view of Reutelingsperger et al. (CMLS: Cell Mol. Life Sci. 53: 527-532 (1997)) as applied to claims 58 above, and in further view of Prien et al. (US Patent 9,157,063).
Fox et al. and Reutelingsperger et al. are discussed supra. Fox et al. and Reutelingsperger et al. differ from the instant invention in failing to teach pH parameters of 6.5 or higher.
Prien et al. teach a method of processing a sperm sample to separate, collect, and enrich X- or Y- chromosome bearing (characteristic or property) sperm cells on the basis of pH environment (Abstract; col. 5, lines 41-47). Prien et al. teach forming a composition comprising the sperm sample and buffered solution; incorporating the composition onto a device comprising biocompatible mesh material that permits flow mobility pathways for sperm cells into sub-chambers (Semen Separation Chambers (SSC)); and then determining X- or Y- chromosome bearing property of the sperm cells in the stream (mobility pathway) (col. 2, line 51 to col. 3, line 14; col. 4, lines 35-37; col. 7, lines 14-25). Each sub-chamber adjusts the sperm composition to a pH of 6.5 and higher up to 9.5 (Abstract; Figure 1; col. 10, line 44 to col. 11, line 67).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have incorporated the teaching of Prien on processing sperm cells on the basis of pH into the method of sorting sperm cells as taught by Fox as modified by Reutelingsperger because Prien specifically taught that it is well known in the art that different pHs affect viability and motility of differing sperm cell populations. One of ordinary skill in the art at the time of filing of the invention would have had reasonable expectation of success in incorporating the teaching of Prien into the method of processing sperm cells as taught by Fox and modified by Reutelingsperger because all of Fox, Reutelingsperger, and Prien teach analogous art in processing cells on the basis of their structural properties.
17. No claims are allowed.
Remarks
18. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Chan et al. (A simple zeta method for sperm selection based on membrane charge. Fertility and Sterility 85 (2): 481-486 (February 2006)) teach using electrostatic charge attraction property to immobilize highly charged sperm while washing away lesser charged sperm and debris (Abstract; p. 431, right col. 1st full ¶).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. 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.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
November 28, 2025