DETAILED ACTION
Notice of AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1-20 are canceled.
Claims 21-30 are pending.
Claim 29 is objected to.
Claims 21-30 are rejected.
Priority
This application US 18/372,565 (02/16/2024) is a CON of US Application No. 15/257,836 (09/06/2016) which is a CIP of US Application No. 13/846,111 (03/18/2013) which is a CON of US Application No. 13/057,350 (03/29/2011) which is a 371 of PCT/US2009/052730 (08/04/2009) which claims benefit of US Application No. 61/137,851 (08/04/2008), US Application No. 61/188,343 (08/08/2008), US Application No. 61/194,854 (10/01/2008) and US Application No. 61/198,690 11/07/2008; and said US Application No. 15/257,836 (09/06/2016) is a CIP of US Application No. 12/994,260 (12/20/2010) which is a 371 of PCT/US09/45335 (05/27/2009) which claims benefit of US Application No. 61/128,961 (05/27/2008) and US Application No. 61/188,343 (08/08/2008) as reflected in the filing receipt mailed on 02/08/2024. The claims to the benefit of priority are acknowledged and the effective filing date of claims 21-30 is 05/27/2008.
Information Disclosure Statement
The information disclosure statement filed 01/17/2025 and 08/12/2025 were considered.
Claim interpretation
The recited “optionally [from /for the] one or more related individuals” in claim 21, is interpreted as a non-requirement because it does not happen in all embodiments of the claimed invention since the recitation is an optional one. Therefore, said recitations are not requirements. The following recitations in claim 22 (wherein the related individuals are siblings of the target individual) and claim 29 (where the related individuals are selected from the group consisting of one or more embryos that are from the same parents, one or more sperm from the father, and combinations thereof) are interpreted as non-requirements since these recitations are intended to further limit the recited “optionally for the one or more related individuals” in claim 1.
Specification Objections
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: multiple lines of the following paragraphs disclose illegible labels or variables – [00156 – 00171, 00182 – 00185, 00189, 00203 – 00211, 00214, 00216, 00228 – 00238, 00241, 00243, 00247 – 00263, 00290 – 00314, 00407, 00444 – 00445, 00451 and 00455].
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim objections
Claim 29 is objected to because of the following informality: the recited “WF” should read “IVF” as it is being interpreted as such. Furthermore, the recited term should be spelled out. If using the term “IVF” the abbreviation should be introduced in claim 23 for proper claim agreement. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 21-30 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
In claim 21, the recited “obtaining genetic data from the target individual, and from the one or both parents, and from any related individuals” is indefinite. It is unclear if the recited “any” refers to at least one related person or refers to any and all related people. Therefore, the metes and bounds of the claim is unclear.
Claims 22-30 recite unclear antecedent basis because the claims depend on claim 1 which has been canceled.
In claim 25, the relationship between the recited “a set of alleles for the target individual” and the recited “a set of alleles, in a target individual” in claim 21. It is unclear if claim 25 refers to the same set of alleles or a different one.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-30 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 21-30) which falls within one of the categories of statutory subject matter. [Step 1: claims 21-30: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mathematical concepts (in particular mathematical relationships and formulas) and mental processes (in particular procedures for observing, analyzing and organizing information) as well as a law of nature or a natural phenomenon are as follows.
Mathematical concepts (in particular mathematical relationships and formulas) include:
• "determining a statistical probability for each allelic hypothesis in the set of hypotheses given the obtained genetic data” (claim 21).
The claims identified above read on math. The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation and determined each element performed by mathematical operation. The step directed to “executing an algorithm to determine statistical probabilities” requires mathematical techniques as the only supported embodiments because it describes a mathematical technique (MPEP 2106.04(a)(2) pertains). Further support for the mathematical techniques used in the claims is provided in the specification at [0121], which discloses algorithms that operate on the input genetic data, they may output a determined statistical probability for each of the hypotheses under consideration. Thus, the recited terms correspond to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). MPEP 2106.04(a)(2) pertains.
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
• "obtaining genetic data from the target individual, and from the one or both parents, and from any related individuals” (claim 21);
• "creating a set of at least one allelic hypothesis for the target individual, and for the one or both parents, and optionally for the one or more related individuals, where the hypotheses describe possible allelic states in the set of alleles" (claim 21);
• "determining the allelic state for each of the alleles in the set of alleles for the target individual, and for the one or both parents, and optionally for the one or more related individuals, based on the statistical probabilities of each of the allelic hypotheses" (claim 21);
• "single nucleotide polymorphisms measured by genotyping array and/or DNA sequencing" (claim 26);
• "using platform response models to determine a characteristic measurement bias of a genotyping technique" (claim 27) and
• "wherein the method is performed alongside or in conjunction with a method that determines a number of copies of a given chromosome segment present in the target individual, and where both methods use a same cell, or group of cells, from the target individual as a source of genetic data" (claim 30).
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind (i.e. concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) or because the method only requires a user to manually determine action based on an added number. Under the BRI, the recited limitations are mental processes because a human mind is also sufficiently capable of reading data values of a list to obtain data; evaluate data to create a hypothesis and determine the allelic state based on the statistical probabilities obtained; determine a characteristic measurement bias of a genotyping technique and determine a number of copies of a given chromosome segment from said data evaluation.
Dependent claims 22-30 recite further steps that limit the judicial exceptions in independent claim 21 and, as such, also are directed to those abstract ideas. For example, claims 22 and 29 recite further details about the related individuals; claims 23-25 and 29 recite further details about the allelic state determination; claims 23-24 and 29 recite further details about the target individual; claim 26 recites further details about the genetic data obtained and claim 28 recites further details about the method for determining an allelic state. Furthermore, the recited “to select at least one embryo” in claim 29 is interpreted as intended use. The “single nucleotide polymorphisms measured by genotyping array and/or DNA sequencing” (claim 26) is considered a product by process limitation, further limiting the type of genetic data being analyzed, and is therefore a judicial exception.
Furthermore, the instant claims recite a natural correlation by correlating the genetic material naturally found in the body with its allelic state determination. (see MPEP 2106.04(b).I).
[Step 2A Prong One: claims 21-30: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
Here in Step 2A, Prong Two, no additional step or element have been identified and therefore there are no integration of judicial exceptions into a practical application.
[Step 2A Prong Two: claims 21-30: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis above, there are no additional elements to provide significantly more than the judicial exception.
[Step 2B: claims 21-30: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
A. Claims 21-24 and 26-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo ("Plasma placental RNA allelic ratio permits noninvasive prenatal chromosomal aneuploidy detection." Nature medicine 13.2:218-223 (2007) – IDS 08/12/2025 citation #586) in view of Cross ("Resolution of trisomic mosaicism in prenatal diagnosis: estimated performance of a 50K SNP microarray." Prenatal Diagnosis: Published in Affiliation With the International Society for Prenatal Diagnosis 27.13:1197-1204 (2007 – IDS 08/12/2025 citation #179) in view of Thornhill ("Molecular diagnostics in preimplantation genetic diagnosis." The Journal of molecular diagnostics: JMD 4.1:11 (2002)), as cited on the attached Form PTO-892.
Claim 21 recites:
obtaining genetic data from the target individual, and from the one or both parents, and from any related individuals;
creating a set of at least one allelic hypothesis for the target individual, and for the one or both parents, and optionally for the one or more related individuals, where the hypotheses describe possible allelic states in the set of alleles
• Lo teaches a method for the detection of fetal chromosomal aneuploidy (i.e. allelic state) noninvasively (pg. 218 col. 1 para. 1); wherein the maternal buffy coat and placental tissue DNA from 119 pairs of pregnant women and their fetuses were genotyped (i.e. obtaining genetic data from the target individual, and from the one or both parents, and from any related individuals) (pg. 219 col. 2 para. 2); wherein it was hypothesized that chromosome dosage could be determined by assessing the ratio between alleles of a SNP in the placenta-expressed RNA, the RNASNP allelic ratio, in a heterozygous fetus where the corresponding ratio in the placenta of a heterozygous trisomic fetus would be 1:2 or 2:1 (i.e. creating a set of at least one allelic hypothesis for the target individual, and for the one or both parents) (pg. 219 col. 1 para. 2).
determining a statistical probability for each allelic hypothesis in the set of hypotheses given the obtained genetic data
• Lo does not teach the recitation above. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) in prenatal mock samples using a dilution series from a male with trisomy and a normal female (pg. 1197 Abstract); wherein data was analyzed by statistical tools in order to test SNP mapping array in detecting mosaicism at various levels (pg. 1198 col. 1 para. 4); wherein genotype call rates for the SNP microarray showed trisomy to be obvious at 20% (i.e. determining a statistical probability for each allelic hypothesis in the set of hypotheses given the obtained genetic data) (pg. 1197 Abstract and Fig. 2).
determining the allelic state for each of the alleles in the set of alleles for the target individual, and for the one or both parents, and optionally for the one or more related individuals …
• Lo does not teach the recitation above. However, Thornhill teaches a review of methods for molecular diagnostics in preimplantation genetic diagnosis (PGD) (pg. 11 Title); wherein PGD is a procedure that allows embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1); wherein DNA analysis from carrier parents was performed (pg. 20 Fig. 3) to identify reliably and accurately the presence of the two different parental mutations (i.e. determining the allelic state for each of the alleles in the set of alleles for the target individual, and for the one or both parents) (pg. 21 col. 2 para. 5).
…based on the statistical probabilities of each of the allelic hypotheses
• Lo does not teach the recitation above. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) in prenatal mock samples using a dilution series from a male with trisomy and a normal female (pg. 1197 Abstract); wherein data was analyzed by statistical tools in order to test SNP mapping array in detecting mosaicism at various levels (pg. 1198 col. 1 para. 4); wherein genotype call rates for the SNP microarray showed trisomy to be obvious at 20% (i.e. determining a statistical probability for each allelic hypothesis in the set of hypotheses given the obtained genetic data) (pg. 1197 Abstract and Fig. 2).
Claim 22 recites:
wherein the related individuals are siblings of the target individual
• The above recitation is interpreted as a non-requirement since recitations further limiting “related individuals” are optional and not required by the scope of the claims. See claim interpretation.
Claim 23 recites:
wherein the allelic state determination is performed in the context of in vitro fertilization, and where the target individual is an embryo
• Lo does not teach the recitation above. However, Thornhill teaches a review of methods for molecular diagnostics in preimplantation genetic diagnosis (PGD) (pg. 11 Title); wherein PGD is a procedure that allows embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1).
Claim 24 recites:
wherein the allelic state determination is performed in the context of non-invasive prenatal diagnosis, and where the target individual is a fetus
• Lo teaches a method for the detection of fetal chromosomal aneuploidy (i.e. allelic state) noninvasively (pg. 218 col. 1 para. 1).
Claim 26 recites:
wherein the genetic data comprise single nucleotide polymorphisms measured by genotyping array and/or DNA sequencing, and wherein the genetic data comprise at least 22 chromosomes of at least 1,000 SNPs each
• Lo does not teach the recitation above. However, Cross teaches statistical analysis for 23 chromosomes from 1 to 22 and X (pg. 1202 Fig. 4); wherein genotype calls and probe intensity data for up to 58960 SNPs across the genome for each sample were extracted (pg. 1198 col. 2 para. 2).
Claim 27 recites:
wherein the method comprises using platform response models to determine a characteristic measurement bias of a genotyping technique
• Lo does not teach the recitation above. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) (pg. 1197 Abstract); wherein six cell lines were used as models (i.e. platform response models) for the proposed SNP mapping array using Chromosome Copy Number Analysis Tool (pg. 1199 col. 1 para. 3) with reported measurements such mapping algorithm detection rate (i.e. characteristic measurement bias of a genotyping technique) (pg. 1200 Table 2).
Claim 28 recites:
wherein the method takes into account a possibility of DNA crossovers that may occur during meiosis
• Lo does not teach the recitation above. However, Thornhill teaches linkage analysis that takes into account markers separated from the mutation by recombination during meiosis (i.e. DNA crossovers that may occur during meiosis) (pg. 22 col. 1 para. 2).
Claim 29 recites:
wherein the target individual is an embryo, and wherein determining the allelic state in the set of alleles of the target individual is performed to select at least one embryo for transfer in the context of WF, and where the related individuals are selected from the group consisting of one or more embryos that are from the same parents, one or more sperm from the father, and combinations thereof
• Lo does not teach the recitation above. However, Thornhill teaches “wherein the target individual is an embryo, and wherein determining the allelic state in the set of alleles of the target individual is performed to select at least one embryo for transfer in the context of WF” as a review of methods for molecular diagnostics in preimplantation genetic diagnosis (PGD) (pg. 11 Title); wherein PGD is a procedure that allows embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1).
• Regarding “where the related individuals are selected from the group consisting of one or more embryos that are from the same parents, one or more sperm from the father, and combinations thereof”, it is interpreted as a non-requirement since recitations further limiting “related individuals” are optional and not required by the scope of the claims. See claim interpretation.
Claim 30 recites:
wherein the method is performed alongside or in conjunction with a method that determines a number of copies of a given chromosome segment present in the target individual, and where both methods use a same cell, or group of cells, from the target individual as a source of genetic data
• Lo does not teach the recitation above. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) (pg. 1197 Abstract); wherein six cell lines were used as models the proposed method for SNP mapping array also using Chromosome Copy Number Analysis Tool (pg. 1198 col. 2 para. 3) (i.e. a number of copies of a given chromosome segment present in the target individual) for analysis of DNA from the six fibroblast cell samples previously genotyped (i.e. where both methods use a same cell, or group of cells, from the target individual as a source of genetic data) (pg. 1198 col. 1 para. 7).
Rationale for combining (MPEP §2142-2143)
Regarding claims 21-24 and 26-30, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Lo in view of Cross and Thornhill because all references disclose methods for investigating the structure of genetic variation. The motivation would have been to:
• obtain greater resolution across the genome for the detection of abnormalities (pg. 1203 col. 2 para. 3 Cross) and
• allow embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1Thornhill).
Therefore it would have been obvious to one of ordinary skill in the art to the analysis of genetic structural variation of Lo to the methods by Cross and Thornhill because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the structure of genetic variation.
B. Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo, Cross and Thornhill as applied to claim 21 above further in view of Mitra ("Digital genotyping and haplotyping with polymerase colonies." Proceedings of the National Academy of Sciences 100.10:5926-5931 (2003)), as cited on the attached Form PTO-892.
Claim 25 recites:
wherein determining the allelic state for each of the alleles in the set of alleles in the target individual comprises determining a phased genotype at a set of alleles for the target individual
• Lo does not teach the recitation above. However, Mitra teaches a method to determine digital genotypes which are precisely quantified by counting molecules of each allele followed by genotype determination and phase determination of three different pairs of SNPs up to 45 kb apart. (i.e. determining a phased genotype at a set of alleles for the target individual) (pg. 5926 col. 2 para. 3).
Rationale for combining (MPEP §2142-2143)
Regarding claim 25, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Lo, Cross and Thornhill in view of Mitra because all references disclose methods for investigating the structure of genetic variation. The motivation would have been to correctly determine the genotype and phase of different pairs of SNPs (pg. 5926 Abstract Mitra).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the analysis of genetic structural variation of Lo, Cross and Thornhill to the methods by Mitra because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the structure of genetic variation.
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 21-22 and 25-26 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3 and 8-9 of US Patent No. 9639657 B2.
• Reference claim 1 teaches instant claim 21.
• Reference claim 2 teaches instant claim 22.
• Reference claims 8-9 teach instant claim 25.
• Reference claim 3 teaches instant claim 26.
Claims 23 and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent No. 9639657 B2 as applied to claims 21-22 and 25-26 above further in view of Thornhill ("Molecular diagnostics in preimplantation genetic diagnosis." The Journal of molecular diagnostics: JMD 4.1:11 (2002)).
• US Patent No. 9639657 B2 does not teach instant claim 23. However, Thornhill teaches a review of methods for molecular diagnostics in preimplantation genetic diagnosis (PGD) (pg. 11 Title); wherein PGD is a procedure that allows embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1).
• US Patent No. 9639657 B2 does not teach instant claim 28. However, Thornhill teaches linkage analysis that takes into account markers separated from the mutation by recombination during meiosis (i.e. DNA crossovers that may occur during meiosis) (pg. 22 col. 1 para. 2).
• US Patent No. 9639657 B2 does not teach instant claim 29. However, Thornhill teaches “wherein the target individual is an embryo, and wherein determining the allelic state in the set of alleles of the target individual is performed to select at least one embryo for transfer in the context of WF” as a review of methods for molecular diagnostics in preimplantation genetic diagnosis (PGD) (pg. 11 Title); wherein PGD is a procedure that allows embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1).
• Regarding “where the related individuals are selected from the group consisting of one or more embryos that are from the same parents, one or more sperm from the father, and combinations thereof”, it is interpreted as a non-requirement since recitations further limiting “related individuals” are optional and not required by the scope of the claims. See claim interpretation.
Rationale for combining (MPEP §2142-2143)
Regarding claims 23 and 28-29, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of US Patent No. 9639657 B2 in view of Thornhill because all references disclose methods for investigating the structure of genetic variation. The motivation would have been to allow embryos obtained by in vitro fertilization to be tested for genetic disorders before they enter the uterus and before pregnancy has begun (pg. 11 col. 1 para. 1Thornhill).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the method for investigating the structure of genetic variation of US Patent No. 9639657 B2 to the methods by Thornhill because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the structure of genetic variation.
Claims 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent No. 9639657 B2 as applied to claims 21-22 and 25-26 above further in view of Lo ("Plasma placental RNA allelic ratio permits noninvasive prenatal chromosomal aneuploidy detection." Nature medicine 13.2:218-223 (2007) – IDS 08/12/2025 citation #586).
• US Patent No. 9639657 B2 does not teach instant claim 24. However, Lo teaches a method for the detection of fetal chromosomal aneuploidy (i.e. allelic state) noninvasively (pg. 218 col. 1 para. 1).
Rationale for combining (MPEP §2142-2143)
Regarding claim 24, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of US Patent No. 9639657 B2 in view of Lo because all references disclose methods for investigating the structure of genetic variation. The motivation would have been to:
• achieve diagnosis of fetal chromosomal aneuploidy from maternal plasma (pg. 219 col. 1 para. 2 Lo).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the method for investigating the structure of genetic variation of US Patent No. 9639657 B2 to the methods by Lo because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the structure of genetic variation.
Claims 27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent No. 9639657 B2 as applied to claims 21-22 and 25-26 above further in view of Lo ("Plasma placental RNA allelic ratio permits noninvasive prenatal Cross ("Resolution of trisomic mosaicism in prenatal diagnosis: estimated performance of a 50K SNP microarray." Prenatal Diagnosis: Published in Affiliation With the International Society for Prenatal Diagnosis 27.13:1197-1204 (2007 – IDS 08/12/2025 citation #179).
• US Patent No. 9639657 B2 does not teach instant claim 27. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) (pg. 1197 Abstract); wherein six cell lines were used as models (i.e. platform response models) for the proposed SNP mapping array using Chromosome Copy Number Analysis Tool (pg. 1199 col. 1 para. 3) with reported measurements such mapping algorithm detection rate (i.e. characteristic measurement bias of a genotyping technique) (pg. 1200 Table 2).
• US Patent No. 9639657 B2 does not teach instant claim 30. However, Cross teaches a DNA single nucleotide polymorphism (SNP) microarray to detect chromosome mosaicism for trisomy (i.e. allelic state) (pg. 1197 Abstract); wherein six cell lines were used as models the proposed method for SNP mapping array also using Chromosome Copy Number Analysis Tool (pg. 1198 col. 2 para. 3) (i.e. a number of copies of a given chromosome segment present in the target individual) for analysis of DNA from the six fibroblast cell samples previously genotyped (i.e. where both methods use a same cell, or group of cells, from the target individual as a source of genetic data) (pg. 1198 col. 1 para. 7).
Rationale for combining (MPEP §2142-2143)
Regarding claims 27 and 30, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of US Patent No. 9639657 B2 in view of Cross because all references disclose methods for investigating the structure of genetic variation. The motivation would have been to obtain greater resolution across the genome for the detection of abnormalities (pg. 1203 col. 2 para. 3 Cross).
Therefore it would have been obvious to one of ordinary skill in the art to substitute the method for investigating the structure of genetic variation of US Patent No. 9639657 B2 to the methods by Cross because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for investigating the structure of genetic variation.
Conclusion
No claims are allowed.
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/F.F.L./Examiner, Art Unit 1685
/JANNA NICOLE SCHULTZHAUS/Examiner, Art Unit 1685
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