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 .
Drawings
The drawings were received on 06 February 2026. 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 44-48, 59, 52, and 54-63 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.
Claim 44, the only independent claim pending, is indefinite with respect to what constitutes the upper limit of the size of an “oligonucleotide”. As presently worded, the claim specifies that an oligonucleotide is “at least four nucleotides in length”; however, it is unclear as to just how large an oligonucleotide can be. Likewise, it is also unclear as to just how large the “immobilized nucleic acid” can be.
Claim 44 is indefinite with respect to what type(s) of “substrate” are encompassed by the claim.
Claim 44 is also indefinite with respect to the width, depth, and length of the “microfluidic channel”.
Claim 44 is indefinite with respect to what constitutes the metes and bounds of “a corresponding first area on a substrate”.
Claim 44 is indefinite with respect to what wavelength(s), intensity, and duration are used to irradiate the substrate.
The term “overlapping” in claim 44 is a relative term which renders the claim indefinite. The term “overlapping” 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 45-48, 50, 52, and 54-63, which depend from claim 44, fail to overcome all of the above-identified issues and are similarly rejected.
Claim 45 is indefinite with respect to what constitutes the metes and bounds of the length, structure, and composition of a “splint”.
Claim 55 is indefinite with respect to what constitute the size(s) of the “openings”.
Response to traversal
Applicant’s representative, at pages 8-13 of the response of 15 December 2025, hereinafter the response, traverses the rejection of claims under 35 USC 112(b).
At page 8 of the response said representative asserts:
Claim 44 is allegedly indefinite with respect to what constitutes the upper limit of the size of an "oligonucleotide" and it is also allegedly unclear as to just how large the "immobilized nucleic acid" can be. Applicant respectfully disagrees. The original application discloses that "oligonucleotide" refers to a single-stranded multimer of nucleotides "from about 2 to about 500 nucleotides in length." Original specification at paragraph [0162]. The original specification also discloses examples of the oligonucleotide lengths. See e.g., original specification at paragraphs [0054], [0057], and [0077]. The original specification additionally discloses examples of the length of a "nucleic acid sequence." See e.g., original specification at paragraph [0161]. In light of the specification, a person with ordinary skill in the art at the time of application filing would understand with reasonable certainty what is claimed with respect to the term "oligonucleotide," as well as how large the "oligonucleotide" and the "immobilized nucleic acid" constructed from oligonucleotides can be. The rejection should be withdrawn.
At page 8 of the response said representative asserts:
Claim 44 is allegedly indefinite with respect to what type(s) of "substrate" are
encompassed by the claim. Applicant respectfully disagrees. The original application discloses what a "substrate" can be. See e.g., original specification at paragraph [0159]…
Claim 44 is allegedly indefinite with respect to the width, depth, and length of the
"microfluidic channel." Applicant respectfully disagrees. The original application discloses examples of a microfluidic channel, including the width and depth….
Claim 44 is allegedly indefinite with respect to what wavelength(s), intensity, and
duration are used to irradiate the substrate. Applicant respectfully disagrees. The original
application discloses examples of irradiation wavelengths, duration, and light dose. See e.g., original specification at paragraph [0096]…
At page 10 of the response said representative asserts:
Claim 44 is allegedly indefinite for reciting "overlapping" which is allegedly a relative
term that renders the claim indefinite. Applicant respectfully disagrees. The original application discloses examples of overlapping areas between the first area and the second area (e.g., X1 and Y1; X1 and Y2; X2 and Y1; or X2 and Y2, as shown in FIG. 2C). Original specification at paragraph [0059].
Claim 45 is allegedly indefinite with respect to what constitutes the metes and bounds of
the length, structure, and composition of a "splint." Applicant respectfully disagrees. The
original application discloses that "splint" refers to an oligonucleotide that, when hybridized to other polynucleotides, acts as a "splint" to position the polynucleotides next to one another. Original specification at paragraph [0168]. The original specification additionally discloses examples of the length of a "splint." See e.g., original specification at paragraph [0169]. In light of the specification, a person with ordinary skill in the art at the time of application filing would understand with reasonable certainty what is claimed with respect to the term "splint." The rejection should be withdrawn.
At page 12 of the response said representative asserts:
Claim 55 is allegedly indefinite with respect to what constitute the size(s) of the "openings." Applicant respectfully disagrees. Applicant submits that the claim does not recite "openings" in isolation; rather, the claim recites "a photomask comprising openings that correspond to a plurality of regions on the substrate." The original application discloses substrate regions (e.g., features), examples of feature sizes, and that feature size can be highly controlled using photomasks having openings that correspond to features on a substrate. See e.g., original specification at paragraphs [0025], [0026], and [0080]. In light of the specification, a person with ordinary skill in the art at the time of application filing would understand with reasonable certainty what is claimed with respect to the recitation of "a photomask comprising openings that correspond to a plurality of regions on the substrate." The rejection should be withdrawn.
The above arguments have been considered and have not been found persuasive. While the specification does provide a variety of examples, it is noted with particularity that such cannot be a limitation. In support of this position attention is directed to page 76, paragraph [0182], of the disclosure wherein applicant asserts:
[0182] The present disclosure is not intended to be limited in scope to the particular
disclosed embodiments, which are provided, for example, to illustrate various aspects of the present disclosure. (Emphasis added)
Given that the disclosure is not intended to limit the scope to particular disclosed embodiments, it is less than clear as to just what does constitute the metes and bounds of the various aspects of the claimed invention, including, but not limited to, the features identified above.
Claim Rejections - 35 USC § 112, Written Description
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.
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 44-48, 50, 52, and 54-63 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 44 is the only independent claim pending. For convenience, it is reproduced below.
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Applicant, at pages 18-19, paragraphs [0042] and [0043], of the disclosure asserts:
[0042] In some examples, the molecules on the array may be nucleic acids, such as
oligonucleotides. The oligonucleotide can be single-stranded or double-stranded. Nucleic acid molecules on an array may be DNA or RNA. The DNA may be single-stranded or double-stranded. The DNA may include, but are not limited to, mitochondrial DNA, cell-free DNA, complementary DNA ( cDNA), genomic DNA, plasmid DNA, cosmid DNA, bacterial artificial chromosome (BAC), or yeast artificial chromosome (Y AC). The RNA may include, but are not limited to, mRNAs, tRNAs, snRNAs, rRNAs, retroviruses, small non-coding RNAs, microRNAs, polysomal RNAs, pre-mRNAs, intronic RNA, viral RNA, cell free RNA and fragments thereof. The non-coding RNA, or ncRNA can include snoRNAs, microRNAs, siRNAs, piRNAs and long nc RNAs.
[0043] The oligonucleotide, such as a first oligonucleotide, a second oligonucleotide, a third oligonucleotide, etc., is at least about 4 nucleotides in length, such as at least any of about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 70, or more, nucleotides in length. In some embodiments, the oligonucleotide is at least 4 nucleotides in length. In some embodiments, the oligonucleotide is less than about 70 nucleotides in length, such as less than any of about 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 8, 6, 5, 4, or fewer, nucleotides in length. In some embodiments, the oligonucleotide is between about 4 and about 70 nucleotides in length, such as between about 4 and about 10 nucleotides in length, between about 5 and about 20 nucleotides in length, between about 10 and about 50 nucleotides in length, and between about 30 and about 70 nucleotides in length. (Emphasis added)
A review of the disclosure fails to find where applicant has provided the nucleotide sequence for any DNA or RNA molecule, much less that which is 70 nucleotides or more in length and which has a specific and substantial utility under 35 USC 101. Such non-disclosure of such essential materials1 has not been found to reasonably suggest that applicant, as of the effective priority date, was in possession of the claimed invention.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 44-48, 50, 52, and 54-63 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.
Response to traversal
Applicant’s representative, at pages 13-16 of the response, traverses the rejection of claims for not satisfying the written description requirement of 35 USC 112. At page 14 of the response it is noted that applicant’s representative directs attention to claim 26. It is noted with particularity that claim 26 was cancelled via the preliminary amendment of November 14, 2023.
At page 14, bridging to page 15 of the response, said representative asserts:
As a first matter, the Office has not provided any rationale for the assertion that particular nucleotide sequences for DNA or RNA molecules - including sequences that are "70 nucleotides or more in length" and have "a specific and substantial utility under 35 USC 101" - constitute "essential materials" for the claimed method under 37 CFR 1.57(d). As discussed above, the claimed subject matter is a method for generating an immobilized nucleic acid and not any specific nucleotide sequence per se. Specific nucleotide sequences, per se, are immaterial to the practice of the claimed method. Moreover, the Examiner has not provided any explanation as to why sequences that are "70 nucleotides or more in length" and have "a specific and substantial utility under 35 USC 101" are essential materials for practicing the claimed method. One skilled in the art would appreciate that the inventor had possession of the claimed method at the time the
application was filed based on the disclosure in the application, which as discussed above
demonstrates that the claimed subject matter was complete and provides distinguishing
identifying characteristics of the claimed method such that it was ready for patenting.
Second, the Office has not considered the knowledge that one of ordinary skill in the art
possessed at the time the application was filed. In this regard, the Federal Circuit in Falko-Gunter Falkner V. Inglis, 448 F.3d 1357 (Fed. Cir. 2006) provides guidance:
[T]he patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. Placed in that context, it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention.
Falko-Gunter Falkner, 448 F.3d 1357, 1366. See also, Capon, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The skill of a person of ordinary skill in the art associated with the subject matter of the pending claims is high, as the skilled artisan generally has a Ph.D. or equivalent level of research experience. Such advanced pre-existing knowledge must be considered when assessing the application for sufficient written description of the claimed method for generating an immobilized nucleic acid, and this high level of skill further supports a finding of sufficient written description for the pending claims. Here, the Office has not shown why the skilled artisan, equipped with the high level of skill in the art pertaining to the claimed method, would need to be provided with particular nucleotide sequences in order to conclude that the inventor possessed the claimed method which is not dependent on any particular nucleotide sequence.
Third, Applicant submits that the PTAB has previously considered and has repeatedly
reversed written description rejections of method claims where the Office has asserted that particular nucleotide sequences are necessary to satisfy the written description requirement of a claimed method.
The above cited arguments have been considered and have not been found persuasive towards the withdrawal of the rejection. As an initial matter, it is noted that the claims are to a “method for generating an immobilized nucleic acid”. The nucleotide sequence of the “immobilized nucleic acid” is not specified. The claimed method does require that one employ a first, second and third oligonucleotides that are “at least four nucleotides in length”. As can be seen in paragraph [0043] of the disclosure, the oligonucleotides can range from “at least 4 nucleotides in length” to “70, or more, nucleotides in length.” As can be seen at page 69 of the disclosure:
An oligonucleotide can be 4 to 10, 10 to 20, 21 to 30, 31 to 40, 41 to 50, 51 to 60, 61 to 70, 71 to 80, 80 to 100, 100 to 150, 150 to 200, 200 to 250, 250 to 300, 300 to 350, 350 to 400, or 400-500 nucleotides in length, for example. (Emphasis added)
A review of the disclosure fails to find where applicant has provided the nucleotide sequence for any oligonucleotide of any length, much less a first, second and third oligonucleotides of any of the specified lengths, and which, when ligated, would be a nucleic acid that has utility under 35 USC 101. In support of this position attention is directed to MPEP , which specifies:
[T]he following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use and, therefore, do not define "substantial utilities":
(A) Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;
(B) A method of treating an unspecified disease or condition;
(C) A method of assaying for or identifying a material that itself has no specific and/or substantial utility;
(D) A method of making a material that itself has no specific, substantial, and credible utility; and
(E) A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility. (Emphasis added)
Such useful nucleotide sequences are deemed to constitute “essential material” under 37 CFR 1.57(d).
The claimed method fairly encompasses the production of “an immobilized nucleic acid” of virtually any sequence through the use of first, second and third oligonucleotides and related splints. A review of the disclosure fails to find where applicant has provided any Sequence Listing that comprises any nucleotide sequence for any oligonucleotide or “splint”. Such nondisclosure has not been found to support the position that applicant was in possession of the claimed method as of the effective filing date (29 June 2022). In support of this position attention is again directed to the decision in 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.
***
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)
Acknowledgement is made of decisions of the Board. It is noted that the decisions of the Board do not have greater legal precedents than the Fed. Cir.
In view of the above analysis and in the absence of convincing evidence to the contrary, the rejections are maintained.
Claim Rejections - 35 USC § 101 (Utility) & 112 (Enablement)
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.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 44-48, 50, 52, and 54-63 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility.
Standard for Utility
Attention is directed to the decision in In re Langer (CCPA, 1974) 183 USPQ 288, at 297:
As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope. Assuming that sufficient reason to question the statement of utility and its scope does exist, a rejection for lack of utility under § 101 will be proper on that basis; such a rejection can be overcome by suitable proofs indicating that the statement of utility and its scope as found in the specification are true. Cf. In re Marzocchi, 58 CCPA 1069, 1073, 439 F.2d 220, 223, 169 USPQ 367, 369 (1971) (involving the enablement requirement of 35 U.S.C. 112, first paragraph). (Emphasis added)
Attention is also directed to MPEP 2107.02 I [R-07.2022], which states in part:
The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements… Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility. (Emphasis added)
Attention is also directed to MPEP 2106 II [R-10.2019], which states in part:
A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason.
Attention is also directed to MPEP 2107.01 I [R-07.2022], which states in part:
Specific Utility
A "specific utility" is specific to the subject matter claimed and can "provide a well-defined and particular benefit to the public." In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir. 2005). This contrasts with a general utility that would be applicable to the broad class of the invention. Office personnel should distinguish between situations where an applicant has disclosed a specific use for or application of the invention and situations where the applicant merely indicates that the invention may prove useful without identifying with specificity why it is considered useful. For example, indicating that a compound may be useful in treating unspecified disorders, or that the compound has "useful biological" properties, would not be sufficient to define a specific utility for the compound. See, e.g., In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967). Similarly, a claim to a polynucleotide whose use is disclosed simply as a "gene probe" or "chromosome marker" would not be considered to be specific in the absence of a disclosure of a specific DNA target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 ("Any EST [expressed sequence tag] transcribed from any gene in the maize genome has the potential to perform any one of the alleged uses…. Nothing about [applicant’s] seven alleged uses set the five claimed ESTs apart from the more than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived from any organism. Accordingly, we conclude that [applicant] has only disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101."). A general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. Contrast the situation where an applicant discloses a specific biological activity and reasonably correlates that activity to a disease condition. Assertions falling within the latter category are sufficient to identify a specific utility for the invention. Assertions that fall in the former category are insufficient to define a specific utility for the invention, especially if the assertion takes the form of a general statement that makes it clear that a "useful" invention may arise from what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973). (Emphasis added)
B. Substantial Utility
"[A]n application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public." Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at issue in Fisher were directed to expressed sequence tags (ESTs), which are short nucleotide sequences that can be used to discover what genes and downstream proteins are expressed in a cell. The court held that "the claimed ESTs can be used only to gain further information about the underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of [the inventor’s] research effort, but only tools to be used along the way in the search for a practical utility…. [Applicant] does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent." Id. at 1376, 76 USPQ2d at 1233-34). Thus a "substantial utility" defines a "real world" use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities. For example, both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a "substantial utility" define a "real world" context of use. An assay that measures the presence of a material which has a stated correlation to a predisposition to the onset of a particular disease condition would also define a "real world" context of use in identifying potential candidates for preventive measures or further monitoring. On the other hand, the following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use and, therefore, do not define "substantial utilities":
(A) Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;
(B) A method of treating an unspecified disease or condition;
(C) A method of assaying for or identifying a material that itself has no specific and/or substantial utility;
(D) A method of making a material that itself has no specific, substantial, and credible utility; and
(E) A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility. (Emphasis added)
Office personnel must be careful not to interpret the phrase "immediate benefit to the public" or similar formulations in other cases to mean that products or services based on the claimed invention must be "currently available" to the public in order to satisfy the utility requirement. See, e.g., Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695 (1966). Rather, any reasonable use that an applicant has identified for the invention that can be viewed as providing a public benefit should be accepted as sufficient, at least with regard to defining a "substantial" utility.
Rationale.
As presently worded, claims 44-63 are drawn to “a method for generating an immobilized nucleic acid”.
Applicant, at pages 18-19, paragraphs [0042] and [0043], of the disclosure asserts:
[0042] In some examples, the molecules on the array may be nucleic acids, such as
oligonucleotides. The oligonucleotide can be single-stranded or double-stranded. Nucleic acid molecules on an array may be DNA or RNA. The DNA may be single-stranded or double-stranded. The DNA may include, but are not limited to, mitochondrial DNA, cell-free DNA, complementary DNA ( cDNA), genomic DNA, plasmid DNA, cosmid DNA, bacterial artificial chromosome (BAC), or yeast artificial chromosome (Y AC). The RNA may include, but are not limited to, mRNAs, tRNAs, snRNAs, rRNAs, retroviruses, small non-coding RNAs, microRNAs, polysomal RNAs, pre-mRNAs, intronic RNA, viral RNA, cell free RNA and fragments thereof. The non-coding RNA, or ncRNA can include snoRNAs, microRNAs, siRNAs, piRNAs and long nc RNAs. (Emphasis added)
[0043] The oligonucleotide, such as a first oligonucleotide, a second oligonucleotide, a third oligonucleotide, etc., is at least about 4 nucleotides in length, such as at least any of about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 70, or more, nucleotides in length. In some embodiments, the oligonucleotide is at least 4 nucleotides in length. In some embodiments, the oligonucleotide is less than about 70 nucleotides in length, such as less than any of about 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 8, 6, 5, 4, or fewer, nucleotides in length. In some embodiments, the oligonucleotide is between about 4 and about 70 nucleotides in length, such as between about 4 and about 10 nucleotides in length, between about 5 and about 20 nucleotides in length, between about 10 and about 50 nucleotides in length, and between about 30 and about 70 nucleotides in length. (Emphasis added)
As evidenced above, the nucleic acid can be RNA such as mRNA, as well as DNA, including cDNA. The aspect that the nucleic acid can be either mRNA or cDNA speaks directly to the nucleic acid being an expressed sequence tag, or EST, which has no known function and, therefore, does not have any specific and substantial utility under 35 USC 101.
The claims do not require that the nucleic acid to ultimately be produced and immobilized even be known at the time of filing, much less require that it be useful under 35 USC 101. Brenner, Comr. Pats. v. Manson, 148 USPQ 689 (U.S. 1966). The case at hand is deemed to be analogous to that set forth in MPEP 2107.01 I B (D), supra, which teaches that “A method of making a material that itself has no specific, substantial, and credible utility” is not considered to have a substantial utility.
For "specific utility", the invention must have a utility specific to the subject matter claimed in contrast with a general utility that would be applicable to the broad class of the invention. According to 35 U.S.C. 101, a specific utility is not a list of potential applications for which the broad class of the invention would also have utility.
While nucleic acids, which satisfy the utility requirements of 35 USC 101, were known at the time of filing, such narrowing limitations have not been read into the claims. See MPEP 2111.01 and Superguide.
Applicant is urged to consider amending the claims such that the claims are drawn to those nucleic acids that unquestionably do have utility under 35 USC 101 and which are adequately supported by the original disclosure.
Claims 44-48, 50, 52, and 54-63 are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Specifically, since the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Response to traversal
Applicant’s representative, at pages 17-19 of the response traverse the rejection of claims under 35 USC 101 and 35 USC 112. At page 17 of the response said representative asserts:
Here, the Office asserts, without providing any substantiating evidence or argument, that "[t]he aspect that the nucleic acid can be either mRNA or cDNA speaks directly to the nucleic acid being an expressed sequence tag, or EST, which has no known function and, therefore, does not have any specific and substantial utility under 35 USC 101." However, as an example contrary to the Office's assertion, an entire book entitled Expressed Sequence Tags (ESTs): Generation and Analysis was published in as early as 2009, detailing "the use of EST technology for other purposes such as expression profiling, analysis of alternative transcripts, and phylogenomics." See About this book, available at https://link.springer.com/book/10.1007/978- 1-60327-136-3. As such, the assertion that an EST does not have specific and substantial utility is misplaced.
The above argument has been considered and has not been found persuasive. As an initial point, it is noted that the claimed method does not specify which sequence(s) of am mRNA/cDNA/expressed sequence tag is/are being produced. Given such, the claimed method has been construed as encompassing the production of any mRNA/cDNA/expressed sequence tag. Given such, attention is directed to MPEP 2107.01 I A:
Similarly, a claim to a polynucleotide whose use is disclosed simply as a "gene probe" or "chromosome marker" would not be considered to be specific in the absence of a disclosure of a specific DNA target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 ("Any EST [expressed sequence tag] transcribed from any gene in the maize genome has the potential to perform any one of the alleged uses…. Nothing about [applicant’s] seven alleged uses set the five claimed ESTs apart from the more than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived from any organism. Accordingly, we conclude that [applicant] has only disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101."). A general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. Contrast the situation where an applicant discloses a specific biological activity and reasonably correlates that activity to a disease condition. Assertions falling within the latter category are sufficient to identify a specific utility for the invention. Assertions that fall in the former category are insufficient to define a specific utility for the invention, especially if the assertion takes the form of a general statement that makes it clear that a "useful" invention may arise from what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973)
Applicant’s representative, at page 18 of the response, asserts:
As an initial matter, the present claims are not directed to a method of making an EST. As such, for the present claims to have utility, there is no requirement that an EST must be known at the time of filing or that an EST must be useful.
Agreement is reached in that the claimed method is not limited to the production of only ESTs. Rather, the claimed method has been construed as encompassing virtually any nucleic acid, including ESTs. In support of this position it is noted that applicant, at pages 18-19, paragraphs [0042] and [0043], of the disclosure asserts:
[0042] In some examples, the molecules on the array may be nucleic acids, such as
oligonucleotides. The oligonucleotide can be single-stranded or double-stranded. Nucleic acid molecules on an array may be DNA or RNA. The DNA may be single-stranded or double-stranded. The DNA may include, but are not limited to, mitochondrial DNA, cell-free DNA, complementary DNA ( cDNA), genomic DNA, plasmid DNA, cosmid DNA, bacterial artificial chromosome (BAC), or yeast artificial chromosome (Y AC). The RNA may include, but are not limited to, mRNAs, tRNAs, snRNAs, rRNAs, retroviruses, small non-coding RNAs, microRNAs, polysomal RNAs, pre-mRNAs, intronic RNA, viral RNA, cell free RNA and fragments thereof. The non-coding RNA, or ncRNA can include snoRNAs, microRNAs, siRNAs, piRNAs and long nc RNAs. (Emphasis added)
Applicant’s representative, at page 18 penultimate paragraph of the response, asserts:
An array comprising the immobilized nucleic acid on the substrate are useful, for example, for determining spatial patterns of abundance and/or expression of a biological target (e.g., mRNAs) in a sample such as cells or a tissue sample. Original specification at the Abstract and paragraph [0120].
The aspect of one producing an array of immobilized nucleic acids, where the nucleic acids can be virtually any nucleic acid, including ESTs that have no known utility, is deemed to constitute a general utility, not a specific utility.
In view of the above analysis and in the absence of convincing evidence to the contrary, the rejections under 35 USC 101 and 35 USC 112(a) are maintained.
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..
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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.
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/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.