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 .
Claim 1 is currently pending and under examination.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is
directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a
natural phenomenon, or an abstract idea) without significantly more.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g., an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claim 1 is directed to one of the statutory classes. Claim 1 is directed to a method for biological analysis (Process).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Claim 1 recites the abstract idea of receiving, organizing and processing data using mental steps and mathematical concepts/relationships. Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection (see MPEP 2106.04). Abstract ideas include certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, determining, evaluating, and organizing information/data (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include:
• Analysis of biological data (mental process, human mind is capable of receiving/collecting data, observing/evaluating, organizing information and mathematical concepts).
• Determining sequences corresponding to the plurality of tagged polynucleotides using the first and second tag sequences (mental process, human mind is capable of receiving/collecting data, observing/evaluating/determining and organizing information)
• Counting polynucleotides for multiple different polynucleotides derived from said tissue sample (mental process, human mind is capable of receiving/collecting data, observing/evaluating, organizing information and mathematical concepts).
Therefore, the claims recite elements that constitute one or more judicial exceptions.
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The claim analysis continues with identifying additional elements beyond the judicial exceptions that might evidence integration of the judicial exceptions into a practical application. The steps or elements in addition to the judicial exceptions are: “providing a plurality of polynucleotides derived from a tissue sample”, “generating tagged polynucleotides”, and “sequencing the tagged polynucleotides”, which is not indicative of integration into practical application. These steps, recited at a high level of generality, comprise routine data gathering, which is considered an insignificant extra-solution activity. This data gathering is required for using the judicial exceptions. (See MPEP 2106.05(g)). There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations, separate from the judicial exceptions, that might potentially render the claims directed to a judicial exception patent eligible. To render the claims patent- eligible, these elements must comprise meaningful limitations that add to or transform the judicial exception to the effect that it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an “inventive concept’. The elements that are in addition to the judicial exception comprise: Providing a plurality of polynucleotides derived from a tissue sample, generating tagged polynucleotides and sequencing the tagged polynucleotides. When considered separately and in combination, these elements do not add significantly more to the judicial exception. These steps are well-understood, routine and conventional activities in the field. For example, Nickerson et al. (U.S. Patent Application Publication US 2009/0163366 A1, published June 25, 2009), disclose providing a plurality of polynucleotides derived from a tissue sample, generating tagged polynucleotides and sequencing the tagged polynucleotides (see Abstract, Page 2, [0015]-[0016] and Pages 3-4, [0053]-[0055]). The claims recite an abstract idea with additional elements. Because these elements are not inventive concepts, the claims do not integrate the abstract idea into a practical application. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, the claims do not qualify as patent-eligible subject matter.
For further information, please see the latest revision of MPEP 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as the guidance on Subject Matter Eligibility, including the 2019 Guidance issued Jan. 7, 2019, and the October 2019 Update, provided on the USPTO website at https:/Awww.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter- eligibility.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Nickerson et al. (U.S. Patent Application Publication US 2009/0163366 A1, published June 25, 2009).
Regarding claim 1, Nickerson teaches a method for biological analysis (Page 2, [0015]-[0016]). Nickerson teaches providing a plurality of polynucleotides derived from a tissue sample (Page 2, [0015]-[0016]). Nickerson teaches generating a plurality of tagged polynucleotides from said plurality of polynucleotides and a plurality of oligonucleotide tags (Abstract, Page 1, [0008] and Page 2, [0015]-[0029]). Nickerson teaches a first tag sequence corresponding to a site within said tissue sample (Abstract, Page 1, [0008], Page 2, [0015]-[0029] and Pages 3-4, [0053]-[0056]). Nickerson teaches a second tag sequence distinguishing said tagged polynucleotide from other tagged polynucleotides of the plurality of tagged polynucleotides (Abstract, Page 1, [0008], Page 2, [0015]-[0029] and Pages 3-4, [0053]-[0056]). Nickerson teaches sequencing said plurality of tagged polynucleotides to determine sequences corresponding to the plurality of polynucleotides, including the first tag sequence and the second tag sequence (Abstract, Page 1, [0008], Page 2, [0015]-[0029] and Pages 3-4, [0053]-[0056]). Nickerson teaches using the sequences determined in step (c) to count polynucleotides for multiple different polynucleotides derived from said tissue sample (Abstract, Page 1, [0003]-[0008], Page 2, [0015]-[0029], Page 3, [0034], Pages 3-4, [0053]-[0058], Page 5, [0064]-[0066], Page 6, [0068]-[0074] and Claim 13).
Nickerson teaches each and every limitation of claim 1 and therefore Nickerson anticipates claim 1.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 2 of prior U.S. Patent No. 10,767,233; The independent claims are completely identical.
This is a statutory double patenting rejection.
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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 8,679,756.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method for sequencing using a first and second multiplex identifier (MID) using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 10,633,702.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or using a system with a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,697,013.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method for multiplex analysis using a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,392,662.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method for multiplex analysis using a composition comprising a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,155,981.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method of analyzing nucleic acids using a multiplex identifier (MID) sequence comprising a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,155,981.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method of analyzing nucleic acids using a multiplex identifier (MID) sequence comprising a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,240,197.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method of counting nucleic acids using a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,280,459.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or perform a method for multiplexed analysis of nucleic acids using a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,337,063.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for biological analysis using a first and second tag sequence and/or using an array for multiplexed analysis of nucleic acids comprising a first and second tag sequence using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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