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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1, drawn to a combination of markers, classified in C12Q1/6888.
II. Claims 2-5, drawn to a kit of PCR primers, classified in C12Q1/6844.
III. Claims 6 and 7, drawn to a method comprising using a combination of markers, classified in C12Q2600/124.
IV. Claims 8-10, drawn to a method of identifying arbor acre broiler germplasm, classified in C12Q2600/156.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are different in design where the combination of markers of Group I may be information in an electronic database or table, and the kit of Group II is nucleic acid molecules made up of nucleotide monomers joined by phosphodiester bonds. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions III and IV are directed to related methods. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed may have different modes of operation where the method of using a SNP combination may be a bioinformatic analysis of data, and the methods using primers may require chemical reagents and enzymes. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I and inventions III and IV, and inventions II and inventions III and IV, are in each case related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case products may be used for different methods. For example the SNP marker as broadly claimed in Group I may be used in methods for identifying germplasm from Gallus varieties other than Arbor Acres (as recited in Groups III and IV), where the markers of Group I do not specify particular alleles at the markers. And the nucleic acids of Group II could be used in methods other than germplasm identification methods of Groups III and IV; for example the primers could be used as capture probed to affinity purify a target biomolecule from a biological sample.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
- The inventions have acquired a separate status in the art in view of their different classification;
- The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
- The inventions require a different field of search (see MPEP § 808.02);
- The inventions are likely to raise non-prior art issues, such as non-prior art issues under 35 USC 101 and/or 35 USC 112(a), which issues would be relevant to one invention, but not the other(s).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Leong C. Lei on 08/13/2025 a provisional election was made without traverse to prosecute the invention of Group IV, claims 8-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-7 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claims 8-10 are objected to because of the following informalities:
Claims 8-10 are objected to for depending from withdrawn claims. In the instant case claims 8 recites “the detection kit as claimed in claim 2”, but claim 2 is withdrawn. Claim 8 can be amended to recite the particular limitations of the kit utilized in the claimed method. In this regard it is also noted that claim 2 recites “the SNP molecular marker combination ….. as claimed in claim 1”, where the subject matter of claim 1 itself withdrawn and is distinct from claim 2 (as set forth in the Requirement above).
Claim 8 is objected to over recitation of the phrase “identifying AA broiler germplasm” because in light of the withdrawal of claim the abbreviation “AA” should be accompanied by the full meaning of the abbreviation at the first instance of the abbreviation in the examined claims. For example, “identifying Arbor Acres (AA) broiler germplasm”. Please note however that the recitation of “AA” and “arbor acres” is addressed below in light of the requirements of 35 USC 112(b).
Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8-10 contains the trademark/trade name “Arbor Acres”, which is a registered trademark and brand name for commercial broiler (meat) chicken breeding stock. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the identified source of germplasm and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 101 and 112b – “Use” Claims
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 8-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8-10 are unclear because the claims are directed to a “method” (as recited in claim 8), but only recited the intended purposed of the method (i.e.: identifying AA broiler germplasm) and “using the detection kit”. As set forth in MPEP 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph
In the instant case there at no practical steps recited as claim limitations, and thus it is unclear what the methods of the claims are intended to encompass or require.
With regard to the requirement for claims to be directed to statutory subject matter, MPEP 2173.05(q) further provides:
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction."
Claims 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim do not set forth any practical steps that constitute a method.
Claim Rejections - 35 USC § 101
Claims 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and natural phenomenon without significantly more.
It is noted that the claims are addressed above, with regard to 35 USC 112b, as unclear where there are no practical steps recited in the claims. In the interests of customer service and compact prosecution, and completeness of the record, the claims are addressed here as a broadest reasonable interpretation of the claims may include judicial exceptions to patentability.
The claim(s) recite(s) use of a kit to identify germplasm, where the kit includes primers for detecting SNP molecular markers (claim 8), and also recite that genotypes “match” target genotypes. The claims thus recite abstract ideas, where “identifying” is a mental process that is the correlation of data and information to reach a conclusion, and determining that any genotypes are a “match” is a judgment that can be performed in the human mind. (MPEP 2106.04(a)(2)(II)). Additionally, where the claims are directed to the association between some genotypes and a biological source of sample material, such an asserted association is natural phenomenon which is the natural constitution of a subject genome (MPEP 2106.04(b)(I).
This judicial exception is not integrated into a practical application because there are no practical steps related to, or performed as a result of, the identifying of the source of a sample.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. In the instant case the claims incorporate the detection kit that includes a PCR primer set. But the elements of the kit are recited at the highest level of generality, and do not require any particular structural elements (e.g.: the claim do not set forth particular SEQ ID NOs of the primers). In this regard it is noted that the analysis of chicken genetic material using nucleic acid primers was well understood, routine and conventional activity in the related art (e.g.: Smith et al (1996)).
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
Identification of germplasm from an Arbor Acres broiler chicken, the method comprising the detection of 25 genotypes in a sample from chicken, the 25 genotypes comprising: TT at position 51 of SEQ ID NO: 1; CC at position 51 of SEQ ID NO: 2; GG at position 51 of SEQ ID NO: 3; AA at position 51 of SEQ ID NO: 4; TT at position 51 of SEQ ID NO: 5; AA at position 51 of SEQ ID NO: 6; AA at position 51 of SEQ ID NO: 7; AA at position 51 of SEQ ID NO: 8; GG at position 51 of SEQ ID NO: 9; GG at position 51 of SEQ ID NO: 10; GG or CG at position 51 of SEQ ID NO: 11; TT at position 51 of SEQ ID NO: 12; AA or AG at position 51 of SEQ ID NO: 13; AA at position 51 of SEQ ID NO: 14; GA or AA at position 51 of SEQ ID NO: 15; GG at position 51 of SEQ ID NO: 16; TT at position 51 of SEQ ID NO: 17; AA at position 51 of SEQ ID NO: 18; GG at position 51 of SEQ ID NO: 19; CC at position 51 of SEQ ID NO: 20; AA at position 51 of SEQ ID NO: 21; CC or TC at position 51 of SEQ ID NO: 22; AG or AA at position 51 of SEQ ID NO: 23; AA at position 51 of SEQ ID NO: 24; and CC at position 51 of SEQ ID NO: 25.
does not reasonably provide enablement for the detection of Arbor Acres broilers with the detection of any other genotypes as generically encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Nature of the invention and breadth of the claims
The claims are directed to the detection of SNP molecular markers for the identification of Arbor Acres broiler germplasm. The claims are sufficiently broad to encompass the detection of any alleles (i.e.: any single nucleotide content) at position 51 of each of SEQ ID NOs 1-25. The claims do not specific any particular allele content at each SNP, and the relevant sequences provided in the Sequence Listing provide an ‘N’ at the 51st position of each sequence; so the breadth of the claim encompasses any genotypes of any alleles in each marker of the SNP molecular marker combination of the claims.
Direction provided by the specification and working example
The application provides an example of the sequencing analysis of genomic material from different chicken breeds (e.g.: Table 3) and from Arbor Acres broilers to determine positions of polymorphic content that have alleles specific to the Arbor Acres broiler animals. The specification provides that 25 SNPs have particular genotypes that are indicative of the Arbor Acres animals of the analysis. The specification teaches that a combination of 25 particular genotypes (Table 1, provided below) sufficiently identifies Arbor Acres animals.
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State of the art, level of skill in the art, and level of unpredictability
The state of the art and level of skill in the art in detecting and quantifying any nucleic acid in a sample is high; but the unpredictability in associating any detected genotype combination with any particular specific animal is also high. The high level of unpredictability is demonstrated by the instant specification and the related art.
Because the claims broadly encompass any genotypes of makers 1-25 (i.e.: the 51st position of each of SEQ ID NO: 1-25) in the particular identification of Arbor Acres germplasm, it is relevant to point out that the application as filed provides only for the particular combination of genotypes in Table 1 (above) as indicative of Arbor Acres animals. The breadth of the genotypes that are generically encompassed by the rejected claims is relevant in light of the recognized genetic diversity among chickens, for example as demonstrated by Smith et al (1996), Moran et al (1993), and Lawal et al (2021).
Quantity of experimentation required
A large amount of experimentation would be required to make and use the invention in the full scope as claimed. Such experimentation would require case:control studies, and validation, to determine what genotypes of the markers of the claims may be associated with an Arbor Acres broiler. Even if such experimentation were to be performed, there is no indication that any associations other than the specific combinations of the claims would in fact be identified as indicative or an Arbor Acres broiler.
Conclusion
Taking into consideration the factors outlined above, including the nature of the invention and breadth of the claims, the state of the art, the level of skill in the art and its high level of unpredictability, the lack of guidance by the applicant and the particular examples, it is the conclusion that an undue amount of experimentation would be required to make and use the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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