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 26 June 2024. 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
PNG
media_image1.png
18
19
media_image1.png
Greyscale
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, (b) / Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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-07.2022]:
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.”
***
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, 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). (Emphasis added)
Holding and Rationale
Claims 1-7, 10-13, 16-23, 34, and 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 1 is indefinite with respect to in, or on, what material(s) are the “one or more than one populations of microdroplets” placed.
Claim 1 is indefinite with respect to how the individual microdroplets in the population(s) of microdroplets are identified and are then treated with an antimicrobial agent.
The term “portion” in claim 1 is a relative term which renders the claim indefinite. The term “portion” 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.
Claim 1 is indefinite with respect to just how one is able to measure viability in each of the microdroplets which can be of a wide range of sizes and can be on any density.
Claims 2-7, 10-13, 16-23, 34, and 63 fail to overcome each of the above issues and are similarly rejected.
It is recognized that a dependent claim must further limit the claim(s) from which it depends. In the present case claim 34, which depends from claim 1, requires incubation of the sample(s) of microbes. Given such, claim 1 must, therefor, encompass embodiments where no incubation occurs. It is less than clear as to how, in the case of claim 1, one assess antimicrobial susceptibility without incubating the bacteria in the microdroplets.
Claim 34 is indefinite with respect to just how long the “different periods of time” are for the samples to be incubated. Acknowledgement is made of the listing of possible time periods in paragraph [0049] of the as-filed disclosure. It is noted that narrowing limitations found in the disclosure cannot be read into the claim(s). In support of this position attention is directed to MPEP 2111.01 [R-07.2022], 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).
To the degree that claim 1 must encompass the embodiments of claims that depend therefrom, claim 1 is similarly rejected.
Response to traversal
At pages 6-8 of the response of 31 October 2025, hereinafter the response, applicant’s representative traverses the rejection of claims under 35 USC 112(b). At page 6, bridging to page 7 of the response said representative asserts:
With respect to claim 1, reason a), Applicant submits that the claim is definite when read in light of the specification because it satisfies the test for definiteness: "whether those skilled in the art would understand what is claimed when the claim is read in light of the specification." M.P.E.P. $2173.02. The failure to recite "in, or on, what material(s) are the 'one or more than one populations of microdroplets' placed" does not render the claim indefinite as recitation of what material the microdroplets are placed on or in is not necessary for one of skill in the art to determine the scope of the claim. Applicant reminds the Examiner that a claim is not indefinite merely because it is broad in scope:
Examiners, however, are cautioned against confusing claim breadth with claim indefiniteness. A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. Instead, a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear.
M.P.E.P. $2173.02 I (emphasis added).
The above argument has been considered and has not been found persuasive. In support of this position attention is directed to paragraph [0095], page 46 of the disclosure. As is asserted to therein:
Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above. (Emphasis added)
Attention is also directed to paragraph [0097] on page 46 of the disclosure. As is asserted therein:
[0097] The terminology used in the description presented herein is not intended to
be interpreted in any limited or restrictive manner. (Emphasis added)
As evidenced above, applicant has asserted that the claimed invention is not limited to that which has been disclosed. Given such, it is less than clear as to just what does constitute the metes and bounds of the various aspects of the claimed invention for as asserted to by applicant, it is something other than what has been “described above”.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1-7, 10-13, 16-23, 34, and 63 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, Enablement
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 1-7, 10-13,16-23, 34, and 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As set forth in Cephalon Inc. v. Watson Pharmaceuticals Inc. 105 USPQ2d 1817, 1821 (CAFC, 2013):
To satisfy section 112 of the 1952 Patent Act, the specification must enable a person of ordinary skill in the art to make and use the invention. 35 U.S.C. § 112, ¶1. This requirement is met when at the time of filing the application one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” In re Wands, 858 F.2d 731, 736-37 [8 USPQ2d 1400] (Fed. Cir. 1988). Whether undue experimentation is required “is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940 [94 USPQ2d 1823] (Fed. Cir. 2010) (citing Wands, 858 F.2d at 737).
The following factors may be considered when determining if a disclosure requires undue experimentation:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
Wands, 858 F.2d at 737 (“Wands factors”); Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372 [52 USPQ2d 1129] (Fed. Cir. 1999) (“The Wands factors, when applied from the proper temporal perspective … are a useful methodology for determining enablement….”). These factors while illustrative are not mandatory. Enzo Biochem, Inc., 188 F.3d at 1371. What is relevant depends on the facts, and although experimentation must not be undue, a reasonable amount of routine experimentation required to practice a claimed invention does not violate the enablement requirement. Id. The burden of proof here is on Watson to show that the Khankari patents are invalid for lack of enablement by clear and convincing evidence. See Auto. Tech. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1281 [84 USPQ2d 1109] (Fed. Cir. 2007).
The nature of the invention, The breadth of the claims, & The state of the prior art
Claims 1 and 34 are deemed to be representative and, for convenience, are reproduced below.
PNG
media_image2.png
436
479
media_image2.png
Greyscale
PNG
media_image3.png
187
488
media_image3.png
Greyscale
As evidenced above, the claimed method fairly encompasses one performing qPCR as well as fluorescent in situ hybridization.
As evidenced above, the volume of the microdroplets ranges from 0.01 pl to 1,000 pl. It is noted that 1 microliter comprises 1,000 nanoliters and that 1 nanoliter comprises 1,000 picoliters
As can be seen in dependent claim 34, the method also encompasses performing a period of incubation. The claims do not recite any limitation whereby the microdroplets are prevented from drying out, vaporizing, therein inhibiting any microbial growth, if not killing any bacteria that may have been present in the microdroplet, irrespective of any antimicrobial having been administered.
The quantity of experimentation necessary
The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. In support of this position, it is noted that the claimed method fairly encompasses the use of any antimicrobial, be it known or developed years into the future. Such antimicrobials are clearly essential starting materials. The amount of effort required to enable the full scope of the claimed invention would constitute undue experimentation. In support of this position attention is directed to Cephalon, 1823:
Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years’ work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983). Likewise, we have held that the amount of experimentation would be undue where: (1) the specification lacks guidance by teaching away from the subject matter that was eventually claimed; and (2) there is evidence of the patentee's own failures to make and use the later claimed invention at the time of the application. See, e.g., AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 [68 USPQ2d 1280] (Fed. Cir. 2003)
The amount of direction or guidance presented,
The amount of guidance provided is limited, generally prophetic, and not commensurate with the scope of the claims.
The disclosure has not been found to provide the nucleotide sequence for any of the listed bacteria, much less the nucleotide sequence for any probe or primer that are essential to performing qPCR and in situ hybridization. Such sequences are deemed to constitute essential material.1
As presently worded, the claimed method requires that the microdroplets are contacted with an antimicrobial. The specification has not been found to enable the treatment of a select microdroplets with any antimicrobial where the microdroplets are of any pattern, including random, and can be of very small size (0.01 pl to 1000 pl).
The presence or absence of working examples
The disclosure has not been found to provide any examples.
The predictability or unpredictability of the art
As noted in In re Fisher 166 USPQ 18 (CCPA, 1970):
In cases involving predictable factors, such as that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
Attention is also directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273 (Fed. Cir. June 2013):
The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even “a considerable amount of experimentation is permissible,” as long as it is “merely routine” or the specification “provides a reasonable amount of guidance” regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360-61 [47 USPQ2d 1705] (Fed. Cir. 1998) (internal quotation omitted). Yet, routine experimentation is “not without bounds.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013).
Our cases have described limits on permissible experimentation in the context of enablement. For example, in ALZA Corp. v. Andrx Pharmaceuticals, LLC, we affirmed a judgment of nonenablement where the specification provided “only a starting point, a direction for further research.” 603 F.3d 935, 941 [94 USPQ2d 1823] (Fed. Cir. 2010) (internal quotation omitted). We concluded that one of ordinary skill “would have been required to engage in an iterative, trial-and-error process to practice the claimed invention even with the help of the … specification.” Id. at 943. In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation “would be excessive, e.g., that it would involve testing for an unreasonable length of time.” 707 F.3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a “diverse and relatively poorly understood group of microorganisms,” with unpredictable heterologous gene expression. Id. at 496.
Here, the specification similarly discloses only a starting point for further iterative research in an unpredictable and poorly understood field. Synthesizing candidate compounds derived from sirolimus could, itself, require a complicated and lengthy series of experiments in synthetic organic chemistry. Even putting the challenges of synthesis aside, one of ordinary skill would need to assay each of at least tens of thousands of candidates. Wyeth's expert conceded that it would take technicians weeks to complete each of these assays. The specification offers no guidance or predictions about particular substitutions that might preserve the immunosuppressive and antirestenotic effects observed in sirolimus. The resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. We thus hold that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation.
In view of the breadth of scope clamed, the limited guidance provided, the unpredictable nature of the art to which the claimed invention is directed, and in the absence of convincing evidence to the contrary, the claims are deemed to be non-enabled by the disclosure.
Response to traversal
At pages 8-10 of the response said representative traverses the rejection of claims under 35 USC 112 for not satisfying the enablement requirement.
At page 9 of the response said representative asserts:
Regarding reason a), a claim scope must be given its broadest reasonable interpretation. It is unreasonable to interpret "incubation" of bacteria when read in light of the specification to include embodiments where the microdroplets dry out or are vaporized.
The above argument has been considered and has not been found persuasive towards the withdrawal of the rejection.
It is noted with particularity that a compound and its properties are inseparable. As presently worded, the claimed method requires the collection of at least one microdroplet that encapsulates “live bacteria from the sample” wherein the “microdroplets each having a volume of 0.01 pl to 1000 pl”. It is noted that 1 microliter comprises 1000 nanoliters, and that 1 nanoliter comprises 1,000 picotiters. The aspect of requiring the microdroplets to range in size of from “0.01 pl to 1000 pl” is deemed to constitute microdroplets that are on the scale of droplets of mist, which can vaporize, therein drying out the bacterial sample. While the disclosure may not refer to the occurrence of microdroplets drying out/vaporizing, such is still natural property of aquatic samples. As presently worded, the claims do not require that one take any measures to protect the microdroplet from vaporizing. Given such, and in the absence of convincing evidence to the contrary, the rejection is maintained.
At page 9 of the response said representative asserts:
Regarding reason b) claims need not enable future discoveries, and the Examiner has failed to articulate any reason that use of existing antibiotics requires any undue experimentation. A conclusory statement is not sufficient to meet the Examiner's burden of articulating a prima facie case.
The above argument has been considered and has not been found persuasive. While argument has been presented that applicant is not responsible for enabling “future discoveries”, no argument has been presented that the claims do not encompass said future discoveries. It is well settled that applicant is responsible for enabling the full scope of that which is claimed. In support of this position attention is directed to the unanimous decision of the US Supreme Court
decision in Amgen Inc., et al. v. Sanofi et al. 598 U.S. ___ (2023):
Our decisions in Morse, Incandescent Lamp, and Holland Furniture reinforce the simple
statutory command. If a patent claims an entire class of processes, machines,
manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405, 419 (1908) (“[T]he claims measure the invention.”).
***
To be fair, Amgen does not dispute this much. It freely admits that it seeks to claim for
itself an entire universe of antibodies. Still, it says, its broad claims are enabled because
scientists can make and use every undisclosed but functional antibody if they simply
follow the company’s “roadmap” or its proposal for “conservative substitution.”
We cannot agree. These two approaches amount to little more than two research
assignments… Whether methods like a “roadmap” or “conservative substitution” might
suffice to enable other claims in other patents—perhaps because, as this Court suggested
in Incandescent Lamp, the inventor identifies a quality common to every functional
embodiment, supra, at 13—they do not here. They leave a scientist about where Sawyer
and Man left Edison: forced to engage in “painstaking experimentation” to see what
works. 159 U. S., at 475. That is not enablement. More nearly, it is “a hunting license.”
Brenner v. Manson, 383 U. S. 519, 536 (1966).
In view of the above analysis and legal guidance, the rejection is maintained.
At page 9 of the response said representative asserts:
Regarding reason c), Applicant notes that claim 1 recites that the bacteria are selected from E. coli, P. aeruginosa, S. aureus, S. epidermidis, E. faecalis, K. pneumoniae, E. cloacae, A. baumanii, S. marcescens, and E. faecium. The specification need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech, Inc. V. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984). M.P.E.P. § 2164.05(a). Here, the Examiner has failed to establish that the sequences of the genomes of the recited bacteria are not known in the art, and therefore constitute "essential material." Applicant reminds the Examiner that the Examiner bears the initial burden of establishing a lack of enablement.
The above argument has been considered and has not been found persuasive towards the withdrawal of the rejection of claims under 35 USC 112(a), enablement. Agreement is reached in that an applicant can incorporate by reference that which is necessary to satisfy the enablement and written description factors of 35 USC 112. As noted above, such material is deemed to constitute “essential material”. As stated therein:
(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.
The nucleotide sequences of the specified bacteria is deemed to constitute essential material as one is not able to practice the required methods of qPCR and fluorescence in situ hybridization without knowledge of such sequences. A review of the disclosure fails to find any Sequence Listing, much less a Sequence Listing that provides the nucleotide sequences of each of the bacteria specified in claim 1- E. coli, P. aeruginosa, S. aureus, S. epidermidis, E. faecalis, K. pneumoniae, E. cloacae, A. baumanii, S. marcescens, and E. faecium. Additionally, a review of the disclosure and response fails to identify where applicant has incorporated by reference those essential sequences. Given such, and in the absence of convincing evidence to the contrary, the rejection is maintained.
Claim Rejections - 35 USC § 101, Judicial Exception
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.
Effective December 16, 2014, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618), which is found at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. These guidelines were updated May 2, 2016, in the Federal Register notice titled May 2016 Subject Matter Eligibility Update, (81 FR 27381), which can be found at: https://www.gpo.gov/fdsys/pkg/FR-2016-05-06/pdf/2016-10724.pdf, and were further updated in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance, (Federal Register, Vol. 84, No. 4, pp. 50-57), which can be found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. In a
Additionally, attention is directed to Gottschalk, Comr. Pats. v. Benson, et al. (US, 1972) 175 USPQ 673, 675:
The Court stated in MacKay Co. v. Radio Corp., 306 U.S. 86, 94, 40 USPQ 199, 202, that “While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.” That statement followed the long-standing rule that “An idea of itself is not patentable.” Rubber-Tip Pencil Co. v. Howard, 20 Wall. 498, 507. “A principle, in the abstract, is a fundamental truth; an original cause; a motive; and these cannot be patented, as no one can claim in either of them an exclusive right.” LeRoy v. Tatham, 14 How. 156, 175. Phenomena of nature, though just discovered, mental processes, abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. As we stated in Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130, 76 USPQ 280, 281, “He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” We dealt there with a “product” claim, while the present case deals only with a “process” claim. But we think the same principle applies. (Emphasis added)
Here the “process” claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure-binary conversion. The end use may (1) vary from the operation of a train to verification of drivers’ licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus. (Emphasis added)
Attention is also directed to the precedential decision in Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc., et al. 115 USPQ2d 1152 (Fed. Cir. 2015):
In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297. If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. Id. at 1298.
***
Mayo made clear that transformation into a patent-eligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features” to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added)
***
Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept.
***
Sequenom and amici encourage us to draw distinctions among natural phenomena based on whether or not they will interfere significantly with innovation in other fields now or in the future. The Supreme Court cases, however, have not distinguished among different laws of nature or natural phenomenon according to whether or not the principles they embody are sufficiently narrow. See, e.g., Parker v. Flook, 437 U.S. 584 (1978) (holding narrow mathematical formula unpatentable). In Parker v. Flook, the Supreme Court stated the issue in the case as follows: “The question in this case is whether the identification of a limited category of useful, though conventional, post-solution applications of such a formula makes respondent’s method eligible for patent protection.” Id. at 585. The answer to that question was “no” because granting exclusive rights to the mathematical formula would be exempting it from any future use.
Claims 4, 17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
As noted in Sequenom:
First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297.
As seen in the Interim Guidelines, one asks the question
Is the claim to a process, machine, manufacture or composition of matter?
In the present case, the claims are to a process, “a method of assessing antimicrobial susceptibility of a live bacteria in a sample”.
Next, in applying Step 2A, Prong 1, of the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG):
Does the claim recite an abstract idea, law of nature, or natural phenomenon?
In the present case, the claim(s) is/are directed to an abstract idea, a mental step. As can be seen in each of claims 4, 17 and 21, one is to perform the step of “comparing” results obtained.
In applying Step 2A, Prong 2, of the 2019 PEG:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
In the present case, the claim(s) have not been found to recite additional elements that integrate the judicial exception into a practical application. .
As noted above in Sequenom,
For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added)
In the present case, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the process set recited in each of claims 4, 17 and 21 is one of “comparing”, which is deemed to be a mental step.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 4, 17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Response to traversal
At page 10 of the response said representative asserts:
Each of dependent claims 4, 17, and 21 ultimately depend from claim 1. Claim 1 recites a method which clearly constitutes "a practical application," namely a method for assessing antimicrobial susceptibility of a live bacteria in a sample. Thus, any alleged judicial exception recited in claims 4, 17 and 21 are integrated into the practical application recited in claim 1, and any intervening dependent claims. For at least the above reason, Applicant respectfully requests withdrawal of the rejection of the claims under 35 U.S.C. § 101.
While agreement is reached in that each of claims 4, 17, and 21 depend from claim 1, it is noted that the only further imitation being provided by claims 4, 17, and 21 is a mental step of “comparing”. Given such, and the absence of convincing evidence to the contrary, the rejections are maintained.
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.
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
Claims 1-7, 10-13, 16-23, 34, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (“High-throughput screening of antibiotic-resistant bacteria in picodroplets”, Lab on a Chip, 16 1636-1643, 2016) in view of US 2006/0182754 A1 (Horwitz et al.), and US 2011/0312510 A1 (Mak et al.).
Liu et al., in the abstract, teach:
Here we demonstrate a novel microfluidic-based picodroplet platform which enables high-throughput assessment and isolation of antibiotic-resistant bacteria in a label-free
manner. As a proof-of-concept, the system was used to isolate fusidic acid-resistant mutants and estimate the frequency of resistance among a population of Escherichia coli (strain HS151). This approach can be used for rapid screening of rare antibiotic-resistant mutants to help identify novel compound/target pairs. (Emphasis added)
Liu et al., at page 1637, left column, third paragraph, teach:
This simple method lays the foundation for novel high-throughput platforms for: a) antibiotic frequency of resistance measurements; b) the isolation of individual AMR phenotypes for DNA sequencing; and c) the potential to discover new AMR mechanisms that could become the targets for antimicrobial drug discovery.
Liu et al., at page 1638, right column, first full paragraph, teach:
Previous work has shown that picodroplets can be used as bioreactors for bacterial proliferation. In this work, we also observed E. coli HS151 can proliferate starting from either one or multiple cells in the picodroplets (Fig. 3A). Furthermore, we developed a method to quantitatively measure the growth kinetics of E. coli in picodroplets.
Liu et al., at page 1641, left column, second paragraph, teach:
To demonstrate the capability of screening for spontaneous antibiotic resistant mutants, HS151 was grown overnight in 3 mL culture media without antibiotics, it was then diluted to 2.7 × 108 CFU mL−1 using fresh culture media supplemented with 16 μg mL− 1 fusidic acid, and the cells were encapsulated into circa 330 pL picodroplets.
Liu et al., have not been found to use fluorescent labeled dye resazurin, nor teach taking readings of bacterial activity at multiple time points, nor specify the concentration of bacteria is less than 2 per microdroplet, which is “0.01 pl to 1000 pl”.
Horwitz et al., in paragraph [0188] teach method of production of single cell bacteria suspensions. As stated therein:
The bacteria were scraped from the plates, diluted in 7H9 broth containing 10% glycerol, sonicated in a water bath to obtain a single cell suspension, and frozen slowly at -70.degree. C. at a concentration of approximately 2x107 viable bacteria/ml. (Emphasis added)
As evidenced above, the cells were diluted out to a concentration of “2x107 viable bacteria/ml”
It is noted that there are 1x103 microliters in 1 milliliter, 1x103 nanoliters in 1 microliter, and 1 x103 picoliters per nanoliters. In converting concentration of cells in Horwitz et al., from a concentration in milliliter to concentration picoliter, one has 2 x 10-2 cells / pl. Such a concentration (0.02 cells/pl) is deemed to fairly suggest the concentration recited in claim 1.
Mak et al., at paragraph [0017] and claim 28, teach and claim method that comprises taking measurements of fluorescent signals multiple times As disclosed therein:
[0017] FIG. 6 demonstrates the correlation of titers determined by fluorescence signal (y-axis) and conventional assay (x-axis) at multiple time points during the post-bactericidal reaction against the MenB NZ98-254 strain. Titer calculations were performed using data from each hourly time point at 4 to 9 hr post bactericidal reaction. (Emphasis added)
28. The method of claim 27, wherein said predetermined time points are selected from the group consisting of every minute, every hour and fractions thereof.
Mak et al., at paragraph [0011], teach:
[0011] Another aspect includes computer-implemented methods of determining a bactericidal activity of a sample toward a pathogen, comprising obtaining, using a processor, a set of metabolic indicator measurements taken at a set incubation time point from a dilution series of incubation cultures, wherein the incubation cultures comprise an amount of the pathogen, complement, and a metabolic indicator and where each of the incubation cultures further comprise a different amount of the sample based upon a predetermined dilution series, wherein the set incubation time point corresponds to a time when the pathogen is rapidly growing in an incubation culture without bactericidal activity; obtaining, using the processor, a set of metabolic indicator measurements taken at the set incubation time point from a dilution series of normalization incubation cultures, wherein the dilution series of normalization incubation cultures corresponds to the dilution series of incubation cultures except that the dilution series of normalization incubation comprise no bactericidal activity; normalizing, using the processor, the set of metabolic indicator measurements using the set of normalizing measurements to produce a set of normalized metabolic indicator measurements; and determining, using the processor, the bactericidal activity of the sample by fitting a sigmoidal curve to the set of normalized metabolic indicator measurements to determine the dilution at which half-maximal growth inhibition occurs.
Mak et al., at paragraph [0121], teach:
[0121] Metabolic indicator. Any bactericidal activity in a sample will result in specific killing of the bacteria added to the assay well, usually within 60 min. Any remaining surviving bacteria can then identified by their metabolic activity using a metabolic indicator that can be detected for example by chromogenic or fluorescent detection, such as alamarBlue (resazurin), during an additional incubation step allowing the surviving bacteria to grow to sufficient detectable levels.
The above showing is deemed to fairly suggest limitations of claim 63.
In view of the above presentation, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Liu et al., to include taking readings of fluorescent signals that are indicative of bacterial cell growth, and to do so over multiple time points, using a bacterial sample where the bacteria had been diluted to a concentration suggested by Horwitz et al. It would have also been obvious to said artisan to have used resazurin as it was known in the art that it enables one to assess metabolic activity of any bacterial in the picodroplet.
In view of the well-developed state of the art said ordinary artisan would have had a most reasonable expectation of success. As noted by Liu et al, such methods “can be used for rapid screening of rare antibiotic-resistant mutants to help identify novel compound/target pairs.” Given such teachings, said ordinary artisan would have been amply motivated.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1-7, 10-13, 16-23, 34, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (“High-throughput screening of antibiotic-resistant bacteria in picodroplets”, Lab on a Chip, 16 1636-1643, 2016) in view of US 2006/0182754 A1 (Horwitz et al.), and US 2011/0312510 A1 (Mak et al.).
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.