DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant's amendments and remarks, filed, 12/04/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. The present application is a divisional of U.S. Application Ser. No. 14/176,830, filed February 10, 2014, which is a continuation application of U.S. Application Ser. No. 13/605,505, filed September 6, 2012, which claims priority to U.S. Application Ser. No. 61/531,738, filed September 7, 2011.
Status of Claims
Claims 3-8 are under examination.
Claims 1-2 are cancelled.
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 3-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Guidance Step 1: The instant invention (claim 3 being representative) is directed to a method, computer readable medium and system that performs a process. Thus, the claims are directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 1, the claimed steps that are part of the abstract idea are as follows:
accessing…a first data set comprising frequency data based on identification of distinguishing regions of the thirty-two for one or more informative loci from the maternal source in the mixed sample;
accessing…a second data set comprising frequency data for one or more informative loci from a fetal source in the mixed sample;
calculating…an estimated fetal source contribution of cell free nucleic based on a binomial distribution of the counts of distinguishing regions from first and second data sets;
accessing…a third data set comprising frequency data for two or more genomic regions from the combined maternal and fetal sources in the mixed sample;
calculating…the presence or absence of a CNV for one or more genomic regions in the fetus by comparison of the frequency data from the two or more genomic regions from the combined maternal and fetal sources in the mixed sample and the estimated fetal source contribution of cell free nucleic acids in the mixed sample.
Mental Processes
Under the BRI, the above steps amount to observing data and analyzing data (e.g. by performing calculations) to generate additional data. As such, the above steps can be performed by the human mind. Notably, the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. Applicant is also reminded that the Office's eligibility guidance does not set limit on the number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. For these reasons, but for the recitation of a processor, the above steps fall within the “mental processes” grouping of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
Mathematical Concept
In addition, the above calculating steps require using ‘binomial distribution’ and comparing frequency data for calculating the presence/absence of CNVs, i.e. mathematical calculations and/or relationships. The instant specification also teaches equations for performing said calculations [pages 8, 21, 22]. Therefore, when read in light of applicant’s own specification, the claims are directed to mathematical concepts. See MPEP 2106.04 and 2106.05(II). [Step 2A, Prong 1: YES].
Natural Correlation
Under the broadest reasonable interpretation, the instant claims require obtaining sequence information from a sample and correlating this with scores that are indicative of CNV. Therefore, the claimed invention amounts to identifying a naturally occurring relationship between data and disease. See MPEP 2106.04(b). It is noted that even if a claim does recite a law of nature or natural phenomenon, it may still be eligible. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not “directed to” that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
B. Guidance Step 2A, Prong 2
Having made that determination, under the 2019 Guidance, the examiner next determines whether there are additional elements beyond the recited abstract idea(s) that integrate them into a practical application. In this case, the additional elements that are not part of the abstract idea are as follows:
measuring a frequency of thirty-two or more informative loci from the fetal source and a frequency of thirty-two or more informative loci from the maternal source;
computer processor and computer readable medium (as in claims 3, 5, 7, and 8)
In this case, the measuring step is not limited to any acts or operations and amounts to necessary gathering of data for use by the abstract idea. As such, this step amounts to “insignificant extra-solution activity” and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
With regards to the claimed processor and CRM, these elements are recited at high level of generality and are merely being used as tools to perform generic computer functions or the abstract idea. As such, these elements amount to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f). Even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
For a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application see MPEP 2106.04(d)(1) 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).
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. Moreover, a review of the specification teaches routine and conventional methods for measuring ‘loci’ frequency (e.g. sequencing or ‘counting’) [0015, 0061] and teaches routine and conventional computer hardware elements for performing the claimed method [0074-0077 and Figure 1]. Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
D. Dependent Claims
Dependent claims 4 and 6, have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. In particular, claims 4 and 6 are directed to limitations that further limit the specificity of the abstract idea set forth above. Accordingly, these claims are also directed to an abstract idea for the reasons set forth above (Step 2A, prong 1 analysis). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more.
Response to Arguments
Applicant’s arguments, filed 12/04/2025, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the computer-implemented process of claim 3 provides an improvement to the technology by analyzing blood, serum or plasma of the patient and using estimated source contributions of cell free nucleic acids based on a binomial distribution of counts to more safely, efficiently, and accurately determine CNV of one or more genomic regions in a single source in a mixed sample.
In response, contrary to applicant’s assertions, the claimed method does not explicitly recite any positive process limitations for analyzing blood, serum, or plasma. Accordingly, applicant’s arguments on this point are not persuasive. That being said, claim 3 (steps b through f) have been interpreted as part of the abstract idea as set forth above (Step 2A, prong 1). Therefore, applicant is essentially arguing that the abstract idea provides the improvement to the technology (e.g. by avoiding physical steps and providing ‘better data’), However, Applicant is reminded that “[i]t has been clear since Alice that a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). On this point, the courts have recently instructed that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.” Board Of Trustees Of Leland Stanford Junior University, 991 F.3d 1245, 1251 (Fed. Cir. 2021). In summary, while appellant’s particular algorithmic approach may be a particular way to achieve an alternative solution for improving CNV calculations, the claimed invention is, nevertheless, directed to an improved algorithmic analysis. As such, the claims do not integrate the recited judicial exception into a practical application.
Applicant argues that the Kingsley Declaration (filed May 19, 2020 in related application 14/176830) provides evidence of the improvement to the technology. In response, this declaration has not yet been filed in the instant application and therefore cannot be properly considered as the instant claims are (at least in part) directed to a different fact pattern. Generally, examiners are not expected to make a qualitative judgement on the merits of an asserted improvement. If the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification. See MPEP § 716.09 on 37 CFR 1.132 practice with respect to rejections under 35 U.S.C. 112(a).
Applicant additionally argues that the instant claim includes elements that are not well-understood, routine, and conventional given the lack of any rejections under 35 USC 102 or 35 USC 103 (suggesting that the Examiner’s Step 2B analysis is improper). In addition, Applicant is reminded that it is improper to conflate 35 USC 101 analysis with prior art analysis under 35 USC 102/103. As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016). See MPEP 2106.05. In other words, it is true that claims can be free of the prior art and yet still rejected under 35 USC 101. That being said, as set forth above in the Step 2B analysis, a review of the specification teaches routine and conventional methods for measuring ‘loci’ frequency (e.g. sequencing or ‘counting’) [0015, 0061] and teaches routine and conventional computer hardware elements for performing the claimed method [0074-0077 and Figure 1]. Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). Thus, the examiner maintains that the independent claim(s) as a whole do not amount to significantly more than the exception itself. For at least these reasons, and absent any evidence to the contrary, the rejection is maintained.
Claim rejections - 35 USC § 112, 2nd Paragraph
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.
Claims 3-8 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 3 and 5 is/are also rejected due to said dependency.
Claims 3, 5, 7, 8 recite (in the preamble) “…one or more genomic regions in a single source in a mixed sample of DNA from blood, serum or plasma of a patient, the mixed sample including a fetal source and a maternal source.” In this case, it is unclear what is meant by “in a single source in a mixed sample” as this phrase raises questions as to what the “single source” actually is (e.g. the fetal source, the maternal source, or otherwise). Clarification is requested via amendment. The examiner suggests amending the claim to recite “from a single source in a mixed sample”.
Claims 3, 5, recite “calculating…the presence or absence of a CNV…by comparison of the frequency data…and the estimated fetal source contribution.” Such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function. More specifically, it is unclear in what way calculating CNV is achieved merely by “comparing” the claimed data (as merely comparing data can be broadly interpreted as qualitative and therefore does not equate to a quantitative calculation). A review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed function. Moreover, the artisan would recognize that there are a number of different computer program and algorithms for detecting CNVs. As a result, it is unclear what computational techniques are included or excluded by the claimed “calculating” such that one of ordinary skill in the art would know how to avoid infringement. Clarification is again requested via amendment, as applicant has not provided any illuminating arguments, pointed to any limiting definitions in the specification, or provided any clarifying amendments to sufficiently address this issue. The MPEP emphasizes that arguments of counsel cannot take the place of evidence in patent cases. See MPEP 2145.
Claims 7, 8 recite “calculating a copy number variation for one or more genomic regions of a single source in the mixed sample by comparison of the frequency data for two or more genomic regions and the estimated source contribution of cell free nucleic acids in the mixed sample.” Such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function. More specifically, it is unclear in what way calculating CNV is achieved merely by “comparing” the claimed data (as merely comparing data can be broadly interpreted as qualitative and therefore does not equate to a quantitative calculation). A review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed function. Moreover, the artisan would recognize that there are a number of different computer program and algorithms for detecting CNVs. As a result, it is unclear what computational techniques are included or excluded by the claimed “calculating” such that one of ordinary skill in the art would know how to avoid infringement. Clarification is again requested via amendment, as applicant has not provided any illuminating arguments, pointed to any limiting definitions in the specification, or provided any clarifying amendments to sufficiently address this issue. The MPEP emphasizes that arguments of counsel cannot take the place of evidence in patent cases. See MPEP 2145.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(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.
Claims 3-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Struble et al. (US2012/0190018; filed: Oct. 15, 2011; Priority date: 1/25/2011).
The applied reference has a common inventor with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under pre-AIA 35 U.S.C. 102(e).
Regarding claim(s) 3, 5, 7, 8, Struble teaches software, computer readable medium containing instructions for performing a method of calculating risk probability for a medical condition based on a comparison of the frequency of a first and second set of data in view of a third data set [see, e.g. Figure 1, Abstract, 0022]. In particular, Struble teaches determining the frequency of a first set of two or more biomolecules in a mixed sample (i.e. measuring loci); wherein the mixed sample can include both maternal samples or fetal samples [0055, 0056, ref. claims 1, 2]. In each case, the recitation of biomolecules makes obvious the feature of one or more informative loci since Struble teaches the biomolecules are associated with loci [ref. claim 25]. Struble does not specifically teach 32 or more informative loci. However, the number of loci is an arbitrary design choice that does not change the function of the claimed process steps, as claimed, and Applicant has not disclosed that this particular feature provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the method of Struble by using 32 or more loci from maternal and fetal sources, as claimed, since Struble clearly teaches determining loci frequency for a plurality of loci using both maternal and fetal sources, as set forth above. The rationale would have been routine optimization of loci data parameters to obtain more significant results.
Struble teaches calculating a biomolecule source contribution from at least a first source in the mixed sample [ref. claim 1], wherein the calculation includes a maximum likelihood estimate using the binomial distribution was used to calculate the estimated fetal nucleic acid contribution across several informative loci in each maternal sample [0113]. Struble additionally teaches obtaining combined frequencies from both the first and second source for each set (i.e. third data set) and then comparing them to determine the presence or absence of a copy number variation in the first or second genomic region [0015], as claimed.
Regarding dependent claim(s) 4 and 6, Struble teaches CNV calculated based on empirical frequence data, as set forth above [ref. claim 1, 0113]. For these reasons, the instant claims do not recite any new element or new function or unpredictable result.
Response to Arguments
Applicant’s arguments, filed 12/04/2025, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the Struble reference should be disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). However, no evidence has been provided to support this assertion but merely citations to different “reel/frame” numbers (and the Examiner has no idea what these are pertaining to). The burden of establishing that subject matter is disqualified as prior art is placed on applicant once the examiner has established a prima facie case of obviousness based on the subject matter. For example, the fact that the reference and the application have the same assignee is not, by itself, sufficient to disqualify the prior art under pre-AIA 35 U.S.C. 103(c). There must be a statement that the common ownership was “at the time the invention was made.” See MPEP § 2146.02 for information regarding establishing common ownership. Absent any evidence, this rejection is maintained for reasons of record.
Statutory 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 Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims 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.
The following rejection is necessitated by amendment.
Claims 3, 5, 7, 8 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 prior U.S. Patent No. US 11,289,176 (application No. 14/176,830). The instant claims 3, 5, 7, 8 are identical in scope compared to reference claim 1 of the ‘176 patent. This is a statutory double patenting rejection.
Non-Statutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Claim(s) 3-8 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim(s) 16, 17, 34, 45, 46, 48, 50 of copending Application No. 13/605,505 (now US 8,712,697).
The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 16 of the ‘505 application teaches all of the limitations of instant claim(s) 3, 5, 7, 8 plus additional features and/or limitations. Therefore, instant claim(s) 3-8 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Claim(s) 3-8 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim(s) 1-14, 16, 17of copending Application No. 14/176,858 (now US 10,847,250).
The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 16 of the ‘858 application teaches all of the limitations of instant claim(s) 3, 5, 7, 8 plus additional features and/or limitations. Therefore, instant claim(s) 3-8 is/are anticipated by the narrower claims (i.e. species anticipates the genus).
Response to Arguments
Applicant’s request that the double patenting rejections be held in abeyance is denied, as applicant has not argued the merits of these rejections and no terminal disclaimer(s) in compliance with 37 C.F.R. 1.321 (c) have been filed to overcome these rejections, as required by 37 C.F.R. 1.130(b).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619