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/Restrictions
Applicant’s election without traverse of SALL1 for claims 8 and 14, and ATAC-seq for claim 13 in the reply filed on 04 September 2024 is acknowledged.
Drawings
The drawings were received on 30 April 2025. These drawings are acceptable.
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
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The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Attention is directed to MPEP 2173.04 [R-10.2019]. As stated therein:
Breadth of a claim is not to be equated with indefiniteness. In re Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140 (CCPA 1970) ("Breadth is not indefiniteness."). A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Claim Rejections - 35 USC § 112, second paragraph / (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.
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-01.2024]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
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During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B [R-01-2024], which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10-2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)
Holding and Rationale
Claims 6-25 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.
The term “more” in each of independent claims 6, 9, and 15 is a relative term which renders the claims indefinite. The term “more” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 6, 9 and 15 are indefinite with respect to what constitutes the metes and bounds of “a subject”.
Claims 7 and 8, which depend from claim 6; claims 10-14 and 23-25, which depend from claim 9; and claims 16-22 which depend from claim 15, fail to overcome the above identified issues and are similarly rejected.
The term “more” in each of dependent claims 7, 15, 17, 23, and 24 is a relative term which renders the claims indefinite. The term “more” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “higher” in claims 6 is a relative term which renders the claim indefinite. The term “higher” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 7 and 8, which depend from claim 1, fail to overcome this issue and are similarly rejected.
The term “increase” in claim 9 is a relative term which renders the claim indefinite. The term “increase” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 10-14, 23, and 24, which depend from claim 9, fail to overcome this issue and are similarly rejected.
Claims 6-25 are indefinite with respect to what constitutes the metes and bounds of “a sample”. Acknowledgement is made of dependent claims 1990 and 18 specifying that it is “a liquid” and claims 11 and 19 specify that it is “a blood sample”; however, it is unclear as to which “liquids” it can be, and it is unclear as to the organism(s) the blood is obtained from.
Claims 8 and 14 are indefinite with respect to what constitutes the metes and bounds of “SALL1”
Claim 9 is indefinite as to just when the limitation of “having analyzed” occurred.
Claim 13 is indefinite with respect to what constitutes the metes and bounds of “ATAC-seq”. It is noted that claim 13 depends from claim 9. Given that claim 13 must be further limiting of claim 9, claim 9 must encompass such an embodiment. Therefore, to the extent that claim 9 encompasses the limitations of claim 13, claim 9 is similarly rejected.
Claim 14 is indefinite with respect to what form of cancer is “GBM”.
Claim 15 is indefinite as to when one had achieved the limitation of “having identified one or more genes in a master regulator network downstream of a master regulator of the cancer.”
Claim 24 is indefinite with respect to what constitutes the metes and bounds of “ATAC-seq” as well as the metes and bounds by which one is “using GeneRep/nSCORE”.
Claim 25 is indefinite with respect to what constitutes the metes and bounds by which “the DNA methylation is detected using ATAC-seq.”
Response to traversal
Applicant’s representative, at pages 7-9 of the response of 30 October 2025, hereinafter the response, traverses the rejection of claims for not satisfying 35 USC 112, second paragraph / (b).
Said representative, at page 8 of the response, asserts:
The Examiner further alleges the metes and bounds of the terms "a sample," "a liquid sample," and "SALL1" are unclear. The Examiner has provided no explanation as to why the metes and bounds of the terms cannot be reasonably determined. As noted above, MPEP 2111 clearly states, "The 'broadest reasonable interpretation' standard is taken 'in light of the specification as it would be interpreted by one of ordinary skill in the art.' [see In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004)] and "In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art." Samples and liquid samples are terms of art readily recognized by those skilled in the art. SALL1 is a gene name that is readily recognized by those skilled in the art. Entries for SALL1 are provided in numerous online databases including GeneCards® The Human Gene Database (https://www.genecards.org/cgi-bin/carddisp.pl?gene=SALL) GenBank (Gene ID 6299, Genome assembly T2T-CHM13v2.0), and UniProt (Ref. no. Q9NSC2).
At page 9 of the response said representative asserts:
The Examiner alleges claim 14 is indefinite with respect to what form of cancer is "GBM." Applicant respectfully disagrees. GBM (glioblastoma multiforme, see claim 8) is a known, specific type of cancer that is readily understood by one skilled in the art.
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The Examiner alleges the metes and bounds of the term "using GeneRep/nSCORE" is unclear. Applicant respectfully disagrees. GeneRep/nSCORE is a specific laboratory technique, like PCR. One skilled in the art can readily identify and put into practice GeneRep/nSCORE analysis of a gene.
The above arguments have been considered and have not been found persuasive towards the withdrawal of the rejection. In support of this position attention is directed to page 20, paragraph [0068], of the disclosure. As is asserted to therein:
Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. (Emphasis added)
As evidenced above, upon reading the disclosure it would be clear that the claims are not limited to that which has been disclosed, and that the terms are used “only” for “descriptive sense”, and are not limiting. Given such, it is less than clear as to just what are the limits of the claimed method.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 6-25 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim Rejections - 35 USC § 112
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.
Standard for Written Description.
Attention is directed to MPEP 2163.02 Standard for Determining Compliance With the Written Description Requirement [R-07-2022]:
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Attention is also set directed to MPEP 2161.01 I [R-07-2022], wherein is stated:
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in Fiers v. Revel 25 USPQ2d 1601, 1604-5 (CAFC, January 1993):
We thus determined that, irrespective of the complexity or simplicity of the method of isolation employed, conception of a DNA, like conception of any chemical substance, requires a definition of that substance other than by its functional utility.
Fiers' attempt to distinguish Amgen therefore is incorrect. We also reject Fiers' argument that the existence of a workable method for preparing a DNA establishes conception of that material. (Emphasis added)
Conception of a substance claimed per se without reference to a process requires conception of its structure, name, formula, or definitive chemical or physical properties...
The difficulty that would arise if we were to hold that a conception occurs when one has only an idea of a compound, defining it by its hoped-for function, is that would-be inventors would file patent applications before they had made their inventions and before they could describe them. That is not consistent with the statute or the policy behind the statute, which is to promote disclosure of inventions.
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
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In Fiers, we rejected the argument that “only similar language in the specification or original claim is necessary to satisfy the written description requirement.” 984 F.2d at 1170 (emphasis added). Rather, we held that original claim language to “a DNA coding for interferon activity” failed to provide an adequate written description as it amounted to no more than a “wish” or “plan” for obtaining the claimed DNA rather than a description of the DNA itself. Id. at 1170-71. That Fiers applied § 112, first paragraph, during an interference is irrelevant for, as we stated above, the statute contains no basis for ignoring the description requirement outside of this context. And again in Enzo we held that generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed. 323 F.3d at 968. We concluded that “[a] claim does not become more descriptive by its repetition, or its longevity.” Id. at 969.
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The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts.
Attention is also directed to MPEP 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement [R-01-2024], at part II ii):
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).") (Emphasis added)
Acknowledgement is made of the fact that the claims are to a method and not to a product. However, it is well settled that in order to satisfy the written description for a method, one must also disclose the molecules required to perform the method. In support of this position attention is directed to University of Rochester v. G.D. Searle & Co. 68 USPQ2D 1424 (W.D.N.Y. 2003) at 1433 (affirmed; University of Rochester v. G.D. Searle & Co. 69 USPQ2d 1886 (Fed. Cir. 2004)):
Plaintiff also argues that the requirements for written descriptions of claims to chemical compounds are irrelevant to this case because the '850 patent does not claim a compound, but a method of treatment by targeting PGHS-2 activity over PGHS-1 activity. Virtually any compound claim could be transformed into a method claim, however, simply by means of wording the claim in terms of a method of using the compound. With respect to the issue before the Court, then, this is little more than a semantic distinction without a difference. The claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment. It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method. Without that substance, the claimed invention is more theoretical than real; it is, as defendants argue, akin to “inventing” a cure for cancer by utilizing a substance that attacks and destroys cancer cells while leaving healthy cells alone. Without possession of such a substance, such a “cure” is illusory, and there is no meaningful possession of the method.
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What the inventors did not do, however, is succeed in taking the last, critical step of actually isolating such a compound, or at least of developing a process through which one skilled in the art would be directly led to such a compound. Absent that step, their discoveries, valuable though they might have been, did not blossom into a full-fledged, complete invention. Scientific discoveries, and theories based on those discoveries, frequently lay the groundwork for later inventions, but that does not make the discoverer the inventor as well.
Attention is also directed to the decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.
(Fed. Cir. 2010) 94 USPQ2d 1161, 1175, which teaches:
In accordance with Rochester, the ?516 patent must adequately describe the claimed methods for reducing NF-?B activity, including adequate description of the molecules that Ariad admits are necessary to perform the methods. (Emphasis added)
Holding and Rationale
Claims 6-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 6, 9, and 15 are the only independent claims pending. Claims 6, 8, 9, 13, 15, and 21 are deemed to be representative and, for convenience, are reproduced below.
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In response to an election of species, applicant elected SALL1 as the downstream target for each of claims 8 and 14 and also elected “ATAC-seq” as the form or type of analysis of chromosomal accessibility and/or methylation in claim 13.
As evidenced above, the method of claims 6 and 9, and dependent claims 8 and 14, respectively, “the cancer is glioblastoma multiform (GBM) and the downstream target[]” is “SALL1”. As seen in claim 9, one is required to perform seep of “analyzing or having analyzed chromosomal accessibility and/or DNA methylation”. As seen in dependent claim 21, “the expression level is analyzed by PCR.”
Each of the above identified methods requires analysis of nucleic acids. Not only does one need to know the nucleotide sequence of the “downstream target”, but one will also need to know the nucleotide sequence of the primers that are required in performing PCR (claims 20 and 21).
A review of the disclosure fails to find where applicant has provided any Sequence Listing, much less a sequence listing that comprises the nucleotide sequence for SALL1 as well as the nucleotide sequence for any target and primer for performing PCR. Such nondisclosure of such essential materials1 by applicant has not been found to reasonably suggest that applicant as in possession of the claimed invention as of the priority date (07 February 2019).
In view of the above analysis and in the absence of convincing evidence to the contrary, 6-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Response to traversal
At page 8, bridging to page 9 of the response said representative traverses the rejection of claims under 35 USC 112(a), for not satisfying the written description requirement. As is asserted to on page 9 of the response:
Applicant has invented, and claims, methods of identifying cancer in a subject by analyzing expression of a "downstream gene" (e.g., SALL1) in a liquid biopsy or analyzing chromosomal accessibility and/or DNA methylation of one or more master regulator genes (e.g., SALL1) in a sample. The sequences of the recited genes are known (e.g., the gene sequence of the SALL 1 gene and the SALL1 genome assembly are available in GenBank: Gene ID 6299, Genome assembly T2T-CHM13v2.0). With knowledge of the gene sequences, one skilled in the art can readily select primers or other nucleic acid sequences suitable for use in the analyses as claimed. (Emphasis added)
The above argument has been considered and has not been found persuasive towards the withdrawal of the rejection. The claimed method requires knowledge of the nucleotide sequences of the “targets” such that “diagnosing a subject with a cancer” is possible. Such sequences are deemed >>essential material<<. Essential material may be incorporated by reference, but that is limited to “an incorporation by reference to a U.S. patent or U.S. patent application publication”.
A review of the disclosure fails to find any Sequence Listing nor any indication that such essential material has been incorporated by reference. Likewise, the response does not identify where the sequences have been disclosed in the application or that this essential material has been properly incorporated by reference. Given this analysis and in the absence of convincing evidence to the contrary, claims 6-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Admissions as Prior Art.
Attention is directed to MPEP 2129 Admissions as Prior Art [R-07.2022], which states in part:
I. ADMISSIONS BY APPLICANT CONSTITUTE PRIOR ART
A statement by an applicant in the specification or made during prosecution identifying the work of another as "prior art" is an admission which can be relied upon for both anticipation and obviousness determinations, regardless of whether the admitted prior art would otherwise qualify as prior art under the statutory categories of 35 U.S.C. 102. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560, 1570, 7 USPQ2d 1057, 1063 (Fed. Cir. 1988). Where the admitted prior art anticipates the claim but does not qualify as prior art under any of the paragraphs of 35 U.S.C. 102, the claim may be rejected as being anticipated by the admitted prior art without citing to 35 U.S.C. 102.
Attention is also directed to Ex parte Shirley, (BPAI, 2009) Appeal No. 2009002352, which, at pages 21 and 26, states:
The Specification’s omission of the term “prior art” and inclusion of the prior-art disclaimer may initially appear to indicate that Appellants do not consider the single-step soft bake process to constitute prior art. To place these latter, contraindicative factors into the proper context though, we note that patent-application drafters regularly endeavor to avoid the indiscriminate or imprudent use of the descriptive label, “prior art.” See Riverwood Intern. Corp. v. R.A. Jones & Co., Inc., 324 F.3d 1346, 1354 (Fed. Cir. 2003) (citing In re Fout, 675 F.2d 297, 300 (CCPA 1982)) for the proposition that “section 102 is not the only source of … prior art. Valid prior art may be created by the admissions of the parties”); In re Nomiya, 509 F.2d 566, 571 (CCPA 1975) (holding that an Applicant’s labeling of certain figures as “prior art,” ipsissimis verbis, constituted an admission that the pictured subject matter was prior art relative to Applicant’s invention); MPEP § 21294 (instructing that “the examiner must determine whether the subject matter identified as ‘prior art’ is applicant’s own work, or the work of another. In the absence of another credible explanation, examiners should treat such subject matter as the work of another”).
***
The Specification’s omission of the term “prior art” and inclusion of the boilerplate prior-art disclaimer do not change our conclusion. In view of the record as a whole, these factors are ineffective in shielding Appellants from having their prior-art admissions treated as such.
Standard for Obviousness.
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 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.
Attention is directed to In re Jung, 98 USPQ2d 1174, 1178 (Fed. Cir. 2011) wherein is stated:
There has never been a requirement for an examiner to make an on-the-record claim construction of every term in every rejected claim and to explain every possible difference between the prior art and the claimed invention in order to make out a prima facie rejection. This court declines to create such a burdensome and unnecessary requirement. “[Section 132] does not mandate that in order to establish prima facie anticipation, the PTO must explicitly preempt every possible response to a section 102 rejection. Section 132 merely ensures that an applicant at least be informed of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.” Chester, 906 F.2d at 1578 (internal citation omitted). As discussed above, all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132. As the statute itself instructs, the examiner must “notify the applicant,” “stating the reasons for such rejection,” “together with such information and references as may be useful in judging the propriety of continuing prosecution of his application.” 35 U.S.C. § 132.
Attention is directed to the decision in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007):
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
It is further noted that prior art is not limited to the four corners of the documentary prior art being applied. Prior art includes both the specialized understanding of one of ordinary skill in the art, and the common understanding of the layman. It includes “background knowledge possessed by a person having ordinary skill in the art. . . [A] court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1396.
Suggestion, teaching or motivation does not have to be explicit and “may be found in any number of sources, including common knowledge, the prior art as a whole or the nature of the problem itself’” Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007) citing Dystar Textilfarben GMBH v. C. H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006).
Holding and Rationale
Claim(s) 6-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0252429 A1 (Price et al.) in view of applicant’s admissions.
Price et al., at paragraph [0008] teach:
[0008] Thus, in one aspect, the invention is directed to a panel for distinguishing among normal brain tissue, samples that harbor meningioma (MNG), samples that harbor ependymoma (EPN), samples that harbor medulloblastoma (MDL), samples that harbor glioblastoma (GBM)… (Emphasis added)
Price et al., paragraph [0030], teach:
[0039] All transcriptomic data used in our analysis are publicly available at the NCBI Gene Expression Omnibus (GEO). We integrated 921 microarray samples of six brain cancers which are ependymoma (EPN), glioblastoma multiforme (GBM), medulloblastoma (MDL), meningioma (MNG), oligodendroglioma (OLG), pilocytic astrocytoma (PA) and normal brain across 16 independent studies into a transcriptome meta-dataset. Importantly, we obtained the raw data (.CEL files) from each of these studies and preprocessed them simultaneously using identical techniques to reduce extraneous sources of technical artifacts (discussed below). All data manipulation and numerical calculations were performed using MATLAB (MathWorks). (Emphasis added)
Price et al., at Table 1, teach:
PNG
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614
480
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Greyscale
(Emphasis added)
Price et al., in claims 1, 11, and 12 claims and discloses:
1. A reagent panel for distinguishing among samples that are normal and samples that harbor cancer wherein said cancer is selected from the group consisting of meningioma (MNG), ependymoma (EPN), medulloblastoma (MDL), glioblastoma (GBM), oligodendroglioma (OLG), and pilocytic astrocytoma (PA) or can distinguish samples that harbor one or more of said cancers from samples that harbor others of said cancers wherein said panel comprises pairs of detection reagents for the expression products of at least one selected gene pair among the following: PRPF40A and PURA; NRCAM and ISLR; IDH2 and GMDS; SALL1 and PAFAH1B3; SRI and NBEA; DDR1 and TIA1 or MAB21L1; ITPKB and PDS5B; NUP62CL and ZNF280A; GALNS and WAS; CELSR1 and OR10H3; TLE4 and OLIG2; DDX27 and KCNMA1; COX7A2 and GNPTAB; GNPTAB and NDUFS2; APOD and PPIA; CD59 and SNRPB2 or HINT1; SEMA3E and ADAMTS3; BAMBI and CIAPIN1; FLNA and TNKS2; ITGB3BP and RB1CC1; DDX27 and TRIM8; and LARP5 and ANXA1. (Emphasis added)
12. A method (a) to distinguish samples that harbor cancer from normal samples which method comprises: determining the level of expression of the PURA gene in said sample from a subject; determining the level of expression of the PRPF40A gene in said sample; comparing the level of expression of PURA and PRPF40A; whereby a higher level of expression of PRPF40A as compared to PURA identifies the sample as harboring cancer and a lower level of expression of PRPF40A as compared to PURA identifies the sample as normal; or (b) to distinguish samples that harbor meningioma (MNG) from samples that harbor alternative forms of cancer which method comprises: determining the level of expression of the NRCAM gene in said sample; determining the level of expression of the ISLR gene in said sample; comparing the level of expression of NRCAM to the level of expression of ISLR; and/or determining the level of expression of the IDH2 gene in said sample; determining the level of expression of the GMDS gene in said sample; comparing the level of expression of IDH2 to the level of expression of GMDS; whereby a higher level of expression of ISLR as compared to NRCAM and/or a higher level of expression of GMDS as compared to IDH2 identifies the sample as harboring MNG; and a lower level of expression of ISLR as compared to NRCAM and/or a lower level of expression of GMDS as compared to IDH2 identifies the sample as harboring an alternative form of cancer; or (c) to distinguish samples that harbor medulloblastoma (MDL) from samples that harbor alternative forms of cancer which method comprises: determining the level of expression of the PAFAH1B3 gene in a sample; determining the level of expression of the SALL1 gene in said sample; and comparing the level of expression of PAFAH1B3 and SALL1; and/or determining the level of expression of the NBEA gene in said sample; determining the level of expression of the SRI gene in said sample; and comparing the level of expression of NBEA to the level of expression of SRI; and/or determining the level of expression of the TIA1 gene or the MAB21L1 gene in said sample; determining the level of expression of the DDR1 gene in said sample; and comparing the level of expression of TIA1 or MAB21L1 to the level of expression of DDR1; and/or determining the level of expression of the PDS5B gene in said sample; determining the level of expression of the ITPKB gene in said sample; comparing the level of expression of PDS5B with ITPKB; whereby a higher level of expression of PAFAH1B3 as compared to SALL1; and/or a higher level of expression of the NBEA gene as compared to the SRI gene; and/or a higher level of the TIA1 gene or MAB21L1 gene as compared to DDR1; and/or a higher level of the PDS5B gene as compared to ITPKB gene identifies the sample as harboring MDL; and a lower level of expression of the PAFAH1B3 gene as compared to SALL1 gene; and/or a lower level of expression of the NBEA gene as compared to SRI gene; and/or a lower level of expression of the TIA1 gene or MAB21L1 gene as compared to DDR1; and/or a lower level of expression of PDS5B as compared to ITPKB identifies the sample as harboring an alternative cancer; or (d) A method to distinguish samples that harbor ependymoma (EPN) from samples that harbor alternative forms of cancer which method comprises: determining the level of expression of the OLIG2 gene in a sample; determining the level of expression of the TLE4 gene in said sample; comparing the level of expression of OLIG2 to the level of expression of TLE4; and/or determining the level of expression of the WAS gene in said sample; determining the level of expression of the GALNS gene in said sample; comparing the level of expression of WAS to the level of expression of GALNS; and/or determining the level of expression of the CELSR1 gene in said sample; and determining the level of expression of the OR10H3 gene in said sample; and comparing the level of expression of CELSR1 to the level of expression of OR10H3; and/or determining the level of expression of the NUP62CL gene in said sample; and determining the level of expression of the ZNF280A gene in said sample; and comparing the level of expression of NUP62CL to the level of expression of ZNF280A; whereby a higher level of expression of TLE4 as compared to the level of expression of OLIG2; and/or a higher level of expression of GALNS as compared to the level of expression of WAS; and/or a higher level of expression of CELSR1 as compared to the level of expression of OR10H3; and/or a higher level of expression of NUP62CL as compared to the level of expression of ZNF280A identifies a sample as harboring EPN; and whereby a lower level of expression of TLE4 as compared to the level of expression of OLIG2; and/or a lower level of expression of GALNS as compared to the level of expression of WAS; and/or a lower level of expression of CELSR1 as compared to the level of expression of OR10H3; and/or a lower level of expression of NUP62CL as compared to the level of expression of ZNF280A identifies a sample as harboring an alternative form of cancer; or (e) to distinguish samples that harbor PA from samples that harbor an alternative form of cancer, which method comprises determining the level of expression of the KCNMA1 gene in a sample; determining the level of expression of the DDX27 gene in said sample; comparing the level of expression of KCNMA1 with that of DDX27; and/or determining the level of expression of the GNPTAB gene in a sample; determining the level of expression of the NDUFS1 gene in said sample; and comparing the level of expression of GNPTAB and NDUFS1; and/or determining the level of expression of the APOD gene in said sample; determining the level of expression of the PPIA gene in said sample; and comparing the level of expression of APOD to the level of expression of PPIA; and/or determining the level of expression of the CD59 gene in said sample; determining the level of expression of the SNRPB1 gene in said sample; and comparing the level of expression of CD59 to the level of expression of SNRPB1; and/or determining the level of expression of the SEMA3E gene in said sample; determining the level of expression of the ADAMTS3 gene in said sample; comparing the level of expression of SEMA3E with ADAMTS3; and/or determining the level of expression of the CD59 gene in said sample; determining the level of expression of HINT1 gene in a sample; comparing the level of expression of CD59 to the level of expression of HINT1; and/or determining the level of expression of the BAMBI gene in said sample; determining the level of expression of the CIAPIN1 gene in said sample; comparing the level of expression of BAMBI to the level of expression of CIAPIN1; wherein a higher level of expression of KCNMA1 as compared to DDX27; and/or a higher level of expression of GNPTAB as compared to NDUFS2; and/or a higher level of expression of APOD as compared to PPIA; and/or a higher level of expression of CD59 as compared to SNRPB2; and/or a higher level of expression of SEMA3E as compared to ADAMT3; and/or a higher level of expression of CD59 as compared to HINT1; and/or a higher level of expression of BAMBI as compared to CIAPIN1 identifies the sample as harboring PA; and a lower level of KCNMA1 as compared to DDX27; and/or a lower level of expression of GNPTAB as compared to NDUFS2; and/or a lower level of expression of APOD as compared to PPIA; and/or a lower level of expression of CD59 as compared to SNRPB2; and/or a lower level of expression of SEMA3E as compared to ADAMT3; and/or a lower level of expression of CD59 as compared to HINT1; and/or a lower level of expression of BAMBI as compared to CIAPIN1 identifies the sample as harboring an alternative form of cancer; or (f) to distinguish samples that harbor GBM from samples that harbor an alternative form of cancer, which method comprises determining the level of expression of the FLNA gene in a sample; and determining the level of expression of the TNKS2 gene in said sample; comparing the level of expression of FLNA with that of TNKS2; and/or determining the level of expression of the ITGB3BP gene in a sample; determining the level of expression of the RB1CC1 gene in said sample; and comparing the level of expression of ITGB3BP and RB1CC1; and/or determining the level of expression of the DDX27 gene in said sample; determining the level of expression of the TRIM8 gene in said sample; and comparing the level of expression of DDX27 to the level of expression of TRIM8; wherein a higher level of expression of FLNA as compared to TNKS2; and/or a higher level of expression of ITGB3P as compared to RB1CC1; and/or a higher level of expression of DDX27 as compared to TRIM8 identifies the sample as harboring GBM; and a lower level of expression of FLNA as compared to TNKS2; and/or a lower level of expression of ITGB3P as compared to RB1CC1; and/or a lower level of expression of DDX27 as compared to TRIM8 identifies the sample as harboring an alternative form of cancer; or (g) to distinguish samples that harbor OLG from samples which harbor an alternative form of cancer which method comprises: determining the level of expression of the ANXA1 gene in said sample; determining the level of expression of the LARP5 gene in said sample; and comparing the level of expression of ANXA1 and LARP5; whereby a higher level of expression of LARP5 as compared to ANXA1 identifies the sample as harboring OLG and a lower level of expression of LARP5 as compared to ANXA1 identifies the sample as harboring an alternative form of cancer. (Emphasis added)
Applicant, at page 6, paragraph [0032], admits:
[0031] Determining or measuring DNA accessibility may be done using methods known in the art. Exemplary methods of determining or measuring DNA accessibility include, but are not limited to, ATAC-seq, CRISPR, DNAse-seq, and MNase-seq[.] (Emphasis added)
[0032] Determining or measuring DNA methylation may be done using methods known in the art. Exemplary methods of determining or measuring DNA methylation include, but are not limited to, ATAC-seq, digestion based assay followed by PCR, methylation specific PCR, E-ice-COLDPCR, bead array analysis, pyrosequencing, PCR with high resolution melting, and bisulfite sequencing. (Emphasis added)
[0033] In some embodiments, ATAC-seq can be used to detect GSC in patient blood. Using A TAC-seq, accessible regions in master regulators of GCS are identified. (Emphasis added)
Applicant, at page 8, paragraph [0037], admits:
[0037] Methods of determining gene expression in a sample can be performed using methods known in the art. Such methods included, but are not limited to, nucleotide amplification assays (including but not limited to PCR, RT-PCR, serial analysis of gene expression, and differential display), microarray technologies, proteomics, HPLC, and Western electrophoresis. (Emphasis added)
In view of the above presentation, it would have been quite obvious to one of ordinary skill in the art to have used known methods in the art to detect SALL1 and in so doing diagnose whether a patient has a form of cancer, including glioblastoma multiform (GBM). In view of the explicit teachings and advanced state of the art, said ordinary artisan would have been amply motivated and would have had a most reasonable expectation of success.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 6-25 remain rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0252429 A1 (Price et al.) in view of applicant’s admissions.
Response to traversal
Applicant’s representative, at pages 10-11 of the response, traverses the rejection of claims under 35 USC 103(a). As seen therein, the traversal is directed only to the teachings of Price et al. The rejection was not one of anticipation under 35 USC 102(b), but one of obviousness, under 35 USC 103(a), which is based on the combined teachings of Price et al., and applicant’s admissions.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 6-25 remain rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0252429 A1 (Price et al.) in view of applicant’s admissions.
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bradley L. Sisson/Primary Examiner, Art Unit 1682
1 Attention is directed to 37 CFR 1.57(d), which sates in part:
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). (Emphasis added)
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.