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 .
Claim Objections
Claims 6, 17, and 18 are objected to because of the following informalities:
a) in claims 6 and 17 either -- C-shaped – and -- V-shaped – should be used or – C-shape – and – V-shape --; and
b) in claim 18, line 1, the article –a – should be inserted between “of” and “source”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “devices” (“. . . ., “wherein the each of the plurality devices produces a signal in response to detecting one or one or more ions, atoms, molecules, or particles traveling through the nanopore.”) in claim 13.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 13-20 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:
a) claim 1 requires “an etch region formed within a portion of the substrate; . . . . [italicizing by the Examiner] ” It Is not clear what is meant by an “etch region”. Does Applicant mean an – etched region--, that is, a region that has been formed by etching? If Applicant is being his own lexicographer please heed MPEP 2173.05(a).
b) claim 13 limitation “devices” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Claim 20, which depends from claim 13, recites “. . . ., wherein the each of the plurality devices produces an electrical, optical, and/or or mechanical signal in response to detecting the one or more atoms or molecules or particles traveling through the nanopore. [underlining by the Examiner]” The disclosure is devoid of any structure that performs the optical and/or mechanical function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Bharath Takulapalli WO 2013/155116 A1 (hereafter “Takulapalli”).
Addressing claim 1, Takulapalli discloses a device (Figure 5, bottom left, final. Product) comprising:
a substrate (the SOI (silicon on insulator) substrate1 shown in the first stage (“Double Conical Nanopore”) of Figure 5, which is eventually silicon buried gate 512 in the final product of Figure 5. See also page 14, lines 5-8, and
page 20, lines 1-5);
an etch region formed within a portion of the substrate (
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This double conical nanopore was formed by etching. See Figure 4 and page 19, lines 17-21.);
an insulating layer (oxygen implantation layer 508) proximate the etch region (Figure 5, next to last stage; and page 20, lines 1-5);
a semiconductor layer (silicon channel 510, which is n+ doped2) formed overlying the insulating layer (Figure 5, next to last stage; and page 20, lines 1-5; and page 20, lines 19-24);
a source region (514 in the last stage of Figure 5) formed using a first portion of the semiconductor layer (page 20, lines 19-24);
a drain region (516 in the last stage of Figure 5) formed using a second portion of the semiconductor layer (page 20, lines 19-24);
a channel formed using a third portion of the semiconductor layer, wherein the channel spans between the source region and the drain region (the Examiner is construing the portion of 510 between the source region 514 and the drain region 516 in Figure 5 as this channel. See also page 20, lines 19-24.); and
one or more nanopores formed within the semiconductor layer (see
Figure 5, the first and last stages)3.
Addressing claim 2, the additional limitation of this claim may be inferred from Figure, the last stage.
Addressing claim 3, for the additional limitation of this claim see Figure 5, last stage, and page 20, lines 19-25.
Addressing claim 5, for the additional limitation of this claim note gate oxide layer 508 in Figure 5. See also page 20, lines 19-25.
Addressing claim 7, for the additional limitation of this claim see annotated Figure 5, which clearly shows that the gate oxide (508) comprises a horizontal section.
Addressing claim 8, for the additional limitation of this claim note the following
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(see Takulapalli page 3).
Also see Takulapalli page 4, lines 5-7; and claim 33.
Addressing claim 9, for the additional limitation of this claim note the following
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(see Takulapalli page 3).
Also see Takulapalli page 4, lines 5-7; and claims 32 and 33.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oura et al. JP 2014190891 A based on an EPO translation (hereafter “Oura”).
Addressing claim 1, Oura discloses a device (Figure 1) comprising:
a substrate (103; paragraph [0015]);
an etch region formed within a portion of the substrate (as a first matter, the Examiner understands “etch region” to mean a region made by etching. So, this limitation is a product-by-process limitation. As such, it is not limited to the manipulation of the recited step (etching), only the structure implied by the step. See MPEP 2113(I). This etch region is clearly visible in Oura Figure 1, although unlabeled, when Oura Figure 1 is viewed alongside Applicant’s Figure 5, noting that 502 is an etch region. See also Applicant’s pre-grant publication, US 20250116650 A1 (hereafter “Applicant’s PG-PUB”, paragraph [0079].4);
an insulating layer (122) proximate the etch region (Figure 1 and paragraph [0022]);
a semiconductor layer (118; since this layer functions as a filed effect transistor (paragraphs [0016] and [0017]) it will inherently be a semiconductor layer) formed overlying the insulating layer (Figure 1);
a source region (115; paragraph [0016]) formed using a first portion of the semiconductor layer (Figure 1);
a drain region (116; paragraph [0016]) formed using a second portion of the semiconductor layer (Figure 1);
a channel (117; paragraph [0016]) formed using a third portion of the semiconductor layer, wherein the channel spans between the source region and the drain region (Figure 1); and
one or more nanopores (102; paragraph [0017]) formed within the semiconductor layer (Figure 1 and Figure 5, which discloses two devices integrated side-by-side).
Addressing claim 2, the additional limitation of this claim may be inferred from Figures 1 and 5.
Claims 13-15 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wenjuan Zhu US 2015/0028846 A1 (hereafter “Zhu”).
Addressing claim 13, Zhu discloses a sensor device (see the title,
Figure 3, and paragraph [0022]) comprising:
a substrate (as a first matter, note that Applicant’s “substrate” is not limited to a single block or layer of material, but is actually a group of layers. See Applicant’s PG-PUB paragraph [0058] and Figure 1 noting substrate 102 therein.5 So the Examiner is construing 100 in Zhu Figures 3 and 1G as the claimed substrate.);
a nanopore (118) formed within the substrate (Figures 1G and 3, and paragraph [0037]; and
a plurality of devices surrounding the nanopore, wherein the each of the plurality devices produces a signal in response to detecting one or one or more ions, atoms, molecules, or particles traveling through the nanopore (as explained in Zhu, the layers above insulating layer 104 in Figures 1G and 3 together form at least four devices as claimed. See Zhu paragraphs [0044]-[0047] and [0056].).
Addressing claim 14, as noted in the rejection of underlying claim 13 there are four devices shown in the Figure 3 embodiment of Zhu. Note that more devices may be added. See paragraph [0051].
Addressing claim 15, the Examiner is broadly construing graphene layers 110 in Figure 3 as “channels” as they are graphene layers that form heterojunctions. See paragraphs [0026] and [0056]. Note that “channels” is undefined by Applicant and so broad that it could even be taken to read on a fluidic channel.
Addressing claim 20, for the additional limitation of this clam see Zhu paragraphs [0046]-[0049], which disclose that each of the plurality devices produces an electrical signal in response to detecting the one or more atoms or molecules or particles traveling through the nanopore.
.
Claim Rejections - 35 USC § 103
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Takulapalli.
Addressing claim 6, as a first matter, Takulapalli meets all of the limitations of underlying claim 5. See the rejection of claim 5 under 35 U.S.C 102(a)(2) above.
In Takulapalli Figure 5 the gate oxide (508) does not comprise a vertical section or C-shaped (concave or convex) or V-shape gate structure; however, to have it comprise a C-shaped (concave or convex) or V-shape gate structure is prima facie obvious as a change in shape with no material effect on operation of the gate oxide or device as a whole (MPEP 2144.04(IV)(B)), especially as the tip of the gate oxide is shown in Figure 5 to already have a triangular convex shape and the nanopore comprises a V-shaped structure. Indeed, see Figures 1 and 8. Also, the following although not directly related to the gate oxide is still relevant for this claim
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(see Takulapalli page 3).
Additionally, see claim 31.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Takulapalli in view of Kang et al., “A Storable Encapsulated Bilayer Chip Containing a Single
Protein Nanopore,” J. AM. CHEM. SOC. 2007, 129, 4701-4705 (hereafter “Kang”).
Addressing claim 10, as a first matter, Takulapalli meets all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C 102(a)(2) above
Takulapalli does not disclose having the device further comprise an encapsulant to encapsulate the device, the encapsulant comprising one or more openings to allow material to come into contact with the device.
Kang discloses a storable encapsulated bilayer chip containing a single nanopore. See the Kang title. The encapsulant comprising an opening to allow material to come into contact with the nanopore. See Figure 1.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to similarly provide an encapsulant as taught by Kang in the device of Takulapalli (see annotated Takulapalli Figure 5 at the end of this claim rejection) because it will protect at least the nanopore region during storage and transport of the device (See Kang page 4703, last sentence in the right column). Also, during use of the device the encapsulant will prevent unnecessary contact between any otherwise exposed exterior surfaces of the device and chemicals and biochemicals in the sample, which may cause undesired reactions and/or noise signals.
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Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Takulapalli in view of Daniel So US 2010/0292101 A1 (hereafter “So”).
Addressing claim 11, Takulapalli does not disclose “. . . ., wherein one or more nano or micro fluidic channels are formed on one or more surfaces of the device.”
So discloses a method and apparatus for analysis and identification of molecules. See the title. The apparatus comprises a microchannel fluidically communicating with the bottom side of a nanopore and a microchannel and a nanochannel fluidically communicating with the top side of the nanopore. See So Figure 8.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to similarly provide microchannels and a nanochannel as taught by So for the device of Takulapalli because (1) Takulapalli discloses, “Each DNA segment may be sequenced simultaneously, with integrated microfluidics, using each of these different FET nanopore device transduction mechanisms… [italicizing by the Examiner]”(see Takulapalli page 24, lines 23-25), and (2) it will allow the device to be part of portable, even hand-held, molecule analyzer, which will increase the convenience of using the device and greatly expand different industries and science areas in which it may be used. See in So the Abstract, Figure 1, and paragraph [0031].
11. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Takulapalli in view of Turner et al. US 2010/0331194 A1 (hereafter “Turner”).
Addressing claim 12, Takulapalli does not disclose “. . . ., wherein multiple devices are formed by stacking the device over another device.”
Turner discloses nanopore sequencing devices and methods. See the title. In one embodiment multiple nanopore devices are formed by stacking one nanopore device over another nanopore device. See Figures 22 and 23. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to similarly provide microchannels and a nanochannel as taught by Turner for the device of Takulapalli because then the device(s) can be used for multi-stage nanopore sequencing, then each stage is configured (for example, by chemical or biochemical functionalization) to be very selective for a particular target analyte, such as a specific nucleic acid molecule. Alternatively, a redundant measurement may be made for statistical confirmation of the initial measurement. See Turner Figure 23 and paragraphs [0176]-[0184].
Allowable Subject Matter
Claims 3, 4, and 17-19 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
a) in claim 3 the combination of limitations includes the following underlined feature
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In contrast, in Takulapalli, as best understood by the Examiner, the source contact. drain contact, and gate contact are formed on different surfaces:
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Likewise, in Oura as best understood by the Examiner, the source contact. drain contact, and gate contact are formed on different surfaces:
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b) claim 4 depends from allowable claim 3.
c) in claim 16 the combination of limitations includes the following underlined features
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In contrast, even if graphene layers 110 in Zhu Figure 3 may be construed as “channels” (see the rejection of claim 3 above under 35 U.S.C. 102(a)(2) using Zhu) there is no source region nor drain region as the devices do not work as FET sensors, but as heterojunction sensors. See Zhu paragraphs [0044]-[0047], [0049], and [0053].
d) in claim 17 the combination of limitations includes the following underlined feature
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In contrast, there is no gate structure shown or suggested for the Zhu Figure 3 embodiment.
e) in claim 18 the combination of limitations includes the following underlined feature
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In contrast, even if graphene layers 110 in Zhu Figure 3 may be construed as “channels” (see the rejection of claim 3 above under 35 U.S.C. 102(a)(2) using Zhu) there is no source contact nor drain contact nor gate contact as the devices do not work as FET sensors, but as heterojunction sensors. See Zhu paragraphs [0044]-[0047], [0049], and [0053].
f) claim 19 depends from allowable claim 18.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Alternative substrate materials are listed in lines 17-20 on page 3.
2 Note that Takulapalli also discloses that a p channel may be formed instead. See page 24, lines 22-25.
3 Note that although only a single nanopore is shown in Figure 5, Takulapalli discloses that an array of nanopores may be formed. See page 16, lines 3-5.
4 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the 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.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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See MPEP 804 II.B.2(a).
5 Ibid.