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`PATENTE rRAoEMARi<'s'
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`iPl.Avv&PoLici" PRODUCTS&SER\llCE§ iN\/ENTORE Newsanonciié FAQ's ABOUT us
`
`2131 Anticipation ——Application of 35 U.S.C. 102 [R-11.2013]
`tiziwhen the invention is
`A claimed Invention may be rejected under 35 U.S.C. 102 linpen-9015-apex-l.htmi#aI dtfbel 2342::
`anticipated (or is “not novel”) over a disclosure that is available as prior art. To anticipate a claim, the disclosure must teach every
`element of the claim.
`
`“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in
`a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir.
`1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed
`anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.” Brown v. 3M, 265 F.3d
`1349, 1351, 60 USPQ2d 1375, 1376 (Fed, Cir. 2001) (claim to a system for setting a computer clock to an offset time to address
`the Year 2000 (Y2K) problem, applicable to records with year date data in “at least one of two-digit, three-digit, or four~digit”
`representations, was held anticipated by a system that offsets year dates in only two-digit formats). See also MPEP § 2131.02
`(s213j.ntmt#dt7c20316§) . “The identical invention must be shown in as complete detail as is contained in the
`claim.” Richardson
`v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required
`by the claim. but this is not an ipsissimis verbls test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15
`USPQ2d 1566 (Fed. Cir. 1990). Note that, in some circumstances, it is pemtissible to use multiple references in a 35 U.S.C. 102
`tmpcp~9015~appx-i.i1tml#r:i0o3023B31 rejection. See MEEP § 2131.01 (s2j§1.htmI#d0e203057i .
`
`2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
`
`Nomtally, only one reference should be used in making a rejection under 35 U 3.0. 10_2_(m1;§1;;9y__i;;§yp;i;i.m3l#doe302383) .
`However. a 35 U.S.C. 102 (mpepv9015~app)(~i.htmI#dOe302383) rejection over multiple references has been held to be proper when
`the extra references are cited to:
`
`-
`-
`~
`
`(A) Prove the primary reference contains an "enabled disclosure;”
`(B) Explain the meaning of a term used in the primary reference; or
`(C) Show that a characteristic not disclosed in the reference is inherent.
`
`See subsections I-Iii below for more explanation of each circumstance.
`
`I. TO PROVE REFERENCE CONTAINS AN “ENABLED DISCLOSURE”
`
`Extra References and Extrinsic Evidence Can Be Used To Show the Primary Reference Contains
`an “Enabled Disclosure”
`
`When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to
`show that the primary reference has an “enabled disclosure.” In re Samour, 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re
`Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims were rejected under gre-AlA_3§__U.S.C. 102(b) (mgep
`-9015~aggx«i.iitmi1id0a302383l over a publication in view of two patents. The publication disclosed the claimed compound structure
`while the patents taught methods of making compounds of that general class. The applicant argued that there was no motivation
`to combine the references because no utility was previously known for the compound and that the 35 U.S.C. 102 (mas)-S015-appx
`~i.htmi#doc3o23B3l rejection over multiple references was improper. The court held that the publication taught all the elements of
`the claim and thus motivation to combine was not required. The patents were only submitted as evidence of what was in the
`public's possession before applicant's invention.).
`
`ii. TO EXPLAIN THE MEANING OF A TERM USED IN THE PRIMARY REFERENCE
`
`Extra References or Other Evidence Can Be Used to Show Meaning of a Term Used in the
`Primary Reference
`
`Extrinsic evidence may be used to explain but not expand the meaning of terms and phrases used in the reference relied upon as
`anticipatory of the claimed subject matter. In re Baxter TIavenolLabs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter
`Travenol Labs. invention was directed to a blood bag system Incorporating a bag containing DEHP, an additive to the plastic
`which improved the bags red blood cell storage capability. The examiner rejected the claims over a technical progress report by
`Becker which taught the same blood bag system but did not expressly disclose the presence of DEHP. The report, however, did
`disclose using commercial blood bags. It also disclosed the blood bag system as “very similar to [Baxter] Travenois commercial
`two bag blood container." Extrinsic evidence (depositions, declarations and Baxter Travenol’s own admissions) showed that
`commercial blood bags, at the time Becker's report was written, contained DEHP. Therefore, one of ordinary skill in the art would
`have known that “commercial blood bags” meant bags containing DEHP. The claims were thus held to be anticipated).
`
`Iii. TO SHOW THAT A CHARACTERISTIC NOT DISCLOSED IN THE REFERENCE IS INHERENT
`
`Extra Reference or Evidence Can Be Used To Show an inherent Characteristic of the Thing
`Taught by the Primary Reference
`
`“To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gapin the reference may
`be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily
`present in the thing described in the reference, and that it would be so recognized by persons of ordlnaiy skill." Continental Can
`
`http://www.uspto.gov/web/officcs/pac/mpep/s2131.htm1
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`6/12/2014
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`DMC Exhibit 2099_001
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`Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that
`“this modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference
`accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where
`technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at
`1749-50.). Note that as long as there is evidence of record establishing Inherency, failure of those skilled in the art to
`contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of
`anticipation. Atlas Powder Co. v. IRECO, Inc, 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art
`references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed,
`in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art
`compositions was "sufficient aeration .
`.
`. entrapped to enhance sensitivity to a substantial degree." The Federal Circuit found that
`the emulsions described in both references would inevitably and inherently have “sufficient aeration“ to sensitize the compound in
`the claimed ranges based on the evidence of record (including test data and expert testimony). This flndlng of Inherency was not
`defeated by the fact that one of the references taught away from air entrapment or purposeful aeration.) See also In re King, 801
`F.2d 1324, 1327, 231 USPQ 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778
`(Fed. Cir. 1985). See MPEP § 2112 is2112.htmi#<loe2o1o36l — § 2112.02 (s2112.html#doe2o13eol for case law on lnherency. Also
`note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124
`(s2124.htmlfld0e2(l2l)94l_.
`
`2131.02 Genus-Species Situations [R-11.2013]
`
`I. A SPECIES WILL ANTICIPATE A CLAIM TO A GENUS
`
`“A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.” The
`species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosfeli,
`872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) (Gosteli claimed a genus of 21 specific chemical species of bicyclic thia-aza
`compounds in Markush claims. The prior art reference applied against the claims disclosed two of the chemical species. The
`parties agreed that the prior art species would anticipate the claims unless applicant was entitled to his foreign priority date.).
`
`II. A REFERENCE THAT CLEARLY NAMES THE CLAIMED SPECIES ANTICIPATES THE CLAIM NO
`MATTER HOW MANY OTHER SPECIES ARE NAMED
`
`A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the
`species claim is anticipated no matter how many other species are additionally named. See Ex parteA, 17 USPQ2d 1716 (Bd. Pat.
`App. & inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held
`that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board
`compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the
`Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is
`used in [pro—AlAl 35 U.S.C. 102(a) lml'>el'>~9015-agpx-l.|1tInI#ci0e302391l , in that publication”). Id. at 1718. See also In re
`Slvaramaknshnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium
`laurate as an additive. The court upheld the Board's finding that a reference specifically naming cadmium laurate as an additive
`amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate
`was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as
`shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not
`disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected
`properties were immaterial).
`
`III. A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT
`DISCLOSURE WHEN THE SPECIES CAN BE “AT ONCE ENV|SAGED” FROM THE DISCLOSURE
`
`depends on the factual aspects of the
`"[W]hether a generic disclosure necessarily anticipates everything within the genus
`specific disclosure and the particular products at issue." Sanofi~Synthe/abo v. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d
`1370, 1375 (Fed. Cir. 2008). See also Osram Sylvania Inc. v. American Induction Tech., 701 F.3d 698, 706, 105 USPQ2d 1368,
`1374 (Fed. Cir. 2012) (“how one of ordinary skill in the art would understand the relative size of a genus or species in a particular
`technology is of critical importance”).
`
`For example, when a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of
`teachings within the reference and combine them, e.g., select various substituents from a list of altematives given for placement at
`specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of
`substiiuents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & inter. 1990). if one of
`ordinary skill in the art is able to "at once envisage” the specific compound within the generic chemical formula, the compound is
`anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds
`included in the generic formula before any of the compounds can be “at once envisaged.” One may look to the preferred
`embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
`
`in in re Petering, the prior art disclosed a generic chemical formula “wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl
`radicals, R a side chain containing an OH group.“ The court held that this fomiula, without more, could not anticipate a claim to 7-
`methyl-9-ld, |'-rihlty|]~isoa||oxa2ine because the generic formula encompassed a vast number and perhaps even an infinite number
`of compounds. However, the reference also disclosed preferred substituents forX, Y, Z, P, R, and R'as follows: where X, P, and
`R' are hydrogen, where Y and 2 may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court
`determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by
`the preferred formula In combination with the fact that the number of substituents was low at each site, the ring positions were
`limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described “each of
`the various permutations here involved as fully as if he had drawn each structural formula or had written each name." The claimed
`compound was 1 of these 20 compounds. Therefore, the reference “described” the claimed compound and the reference
`anticipated the claims.
`
`In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a specific compound were anticipated because the prior
`art taught a generic formula embracing a limited number of compounds closely related to each other in structure and the
`properties possessed by the compound class of the prior art was that disclosed for the claimed compound. The broad generic
`formula seemed to describe an infinite number of compounds but claim 1 was limited to a structure with only one variable
`
`‘
`
`;
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`http2//www.uspto.gov/web/offices/pac/mpep/s2131.html
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`DMC Exhibit 2099_002
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`substituent R. This substituent was limited to low aikyi radicals. One of ordinary skill in the art would at once envisage the subject
`matter within claim 1 of the reterence.).
`
`Compare In re Meyer, 599 F.2d 1026, 202 USPQ 175 (CCPA 1979) (A reference disclosing “alkaline chlorine or bromine solution”
`embraces a large number of species and cannot be said to anticipate claims to “alkali metal hypochlorite.”); Akzo
`N.V.v./nternal/‘onal Trade Comm’n, 808 F.2d 1471, 1 USPQ2d 1241 (Fed. Cir. 1986) (Claims to a process for making aramid fibers
`using a 98% solution of sulfuric acid were not anticipated by a reference which disclosed using sulfuric acid solution but which did
`not disclose using a 98% concentrated sulfuric acid soiution.). See MPEP § 2144.08 (s2144.§ttmI#d0e211596) for a discussion of
`obviousness in genus-species situations.
`
`2131.03 Anticipation of Ranges [R-11.2013]
`
`I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES
`THE RANGE
`
`“[Wjhen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is
`in the prior art.” Titanium Mela/s Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In rePeten'ng, 301 F.2d
`676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-
`O.4% molybdenum (M0) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an
`actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed
`range of composltions.).
`
`II. PRIOR ART WHICH TEACHES A RANGE OVERLAPPING OR TOUCHING THE CLAIMED RANGE
`ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH “SUFFICIENT
`SPECIFICITY”
`
`When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the
`claimed range are disclosed, a case by case determination must be made as to anticipation. in order to anticipate the claims, the
`claimed subject matter must be disclosed In the reference with “sufficient specificity to constitute an anticipation under the statute."
`What constitutes a “sufficient specificity” is fact dependent. if the claims are directed to a narrow range, and the reference teaches
`a broader range, other facts of the case, must be considered when determining whether the narrow range is disclosed with
`“sufficient specificity” to constitute an anticipation of the claims. Compare Clearvalue Inc. v. Pear! R/ver Polymers Inc., 668 F.3d
`1340, 101 USPQ2d 1773 (Fed. Cir. 2012) with Atoflna v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423
`(Fed. Cir. 2006).
`
`in C/earvalue, the claim at issue was directed to a process of clarifying water with alkalinity below 50 ppm, whereas the prior art
`taught that the same process works for systems with alkalinity of 150 ppm or less. in holding the claim anticipated, the court
`observed that “there is no allegation of criticaiity or any evidence demonstrating any difference across the range." Id. at 1345, 101
`USPQ2d at 1777. In Atorina, the court held that a reference temperature range of 100-500 degrees C did not describe the claimed
`range of 330-450 degrees C with sufficient specificity to be anticipatory, even though there was a slight overlap between the
`reference’s preferred range (150-350 degrees C) and the claimed range. “[T]he disclosure of a range is no more a disclosure of
`the end points of the range than it is each of the intermediate points.” id. at 1000, 78 USPQ2d at 1424. Patentee described
`claimed temperature range as "critical" to enable the process to operate effectively, and showed that one of ordinary skill would
`have expected the synthesis process to operate differently outside the claimed range.
`
`if the prior art disclosure does not disclose a claimed range with “sufficient specificity’ to anticipate a claimed invention, any
`evidence of unexpected results within the narrow range may render the claims unobvious. See MPEP § 716.02
`(s716.htniliid0e92844) et seq. The question of "sufficient specificity" is similar to that of "clearly envlsaging" a species from a generic
`teach1ng.See MPEP § 2131.02 (s2131.t1tmI#tl0a20Iii66l .
`
`A 35 USC. 102 (mp_ep-9015-appx~i.htmii1dflo302383) /103 (mpep-9015-appx-l.html)¥d0o302450) combination rejection is permitted if It
`is unclear if the reference teaches the range with “sufficient specificity.” The examiner must, in this case, provide reasons for
`anticipation as well as a reasoned statement regarding obviousness. Ex pane Lee, 31 USPQ2d 1105 (Ed. Pat. App. & inter. 1993)
`
`(expanded Board). For a discussion of the obviousness of ranges see
`
`III. PRIOR ART WHICH TEACHES A VALUE OR RANGE THAT IS VERY CLOSE TO, BUT DOES
`NOT OVERLAP OR TOUCH, THE CLAIMED RANGE DOES NOT ANTICIPATE THE CLAIMED
`RANGE
`
`“[A]nticipation under §_102 (mpep-ant5-appx-i.hlnil#al d1fbe1 zaited 5zLcan be found only when the reference discloses exactly
`what is claimed and that where there are differences between the reference disclosure and the claim, the rejection must be based
`
`
`on §,,fl,Q3_(mpsp;g9 ,;apQ3g;
`tmlgig,l,,,,d,1jbg,1_
`,,t_),Z_1.-1jI_,,b_(z)_which takes differences Into account." Titanium Metals Corp. v. Banner, 778
`F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims to titanium (Ti) alloy with 0.8% nickel (Ni) and 0.3% molybdenum (Mo) were not
`anticipated by, although they were held obvious over, a graph in a Russian article on Ti-Mo-Ni alloys in which the graph contained
`an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% N|.).
`
`2131.04 Secondary Considerations [R-08.2012]
`
`Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 tntpnpw
`9015-aggx-l.htmI#d0e302383l rejections and thus cannot overcome a rejection so based. in re Vi/iggins, 488 F.2d 538, 543, 179
`USPQ 421, 425 (CCPA 1973).
`
`2131.05 Nonanalogous or Disparaging Prior Art [R-08.2012]
`
`“Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or teaches away from the invention’ or is not recognized as
`solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102 (mpeg~9o15-apgx-
`i.htm|tid0g302§§3) .” Twin Disc, lnc.v. United States, 231 USPQ 417, 424 (Ci. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213
`USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68
`USPQ2d 1481, 1488 (Fed. Cir. 2003) (The question of whether a reference is analogous art is not relevant to whether that
`
`http://www.uspto.goV/web/offices/pac/mpep/s2131.html
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`DMC Exhibit 2099_003
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`reference anticipates. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may
`be from an entirely different field of endeavor than that ofthe claimed invention, yet the reference is still anticipatory if it explicitly
`or inherently discloses every limitation recited in the claims.).
`
`A reference is no less anticipatory if, after disclosing the invention, the reference then dlsparages it. The question whether a
`reference “teaches away" from the invention is inapplicable to an anticipation analysis. Celeritas Technologies Ltd. v. Rockwell
`Infematlonal Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The prior art was held to anticipate the
`claims even though it taught away from the claimed invention. “The fact that a modern with a single carrier data signal is shown to
`be less than optimal does not vitiate the fact that it is disclosed”). See Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323,
`75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(claimed composition that expressly excluded an Ingredient held anticipated by reference
`composition that optionally included that same ingredient); see also At/as Powder Co. v. /RECO, Inc, 190 F.3d 1342, 1349. 51
`USPQ2d 1943, 1948 (Fed. Cir. 1999) (Claimed composition was anticipated by prior art reference that inherently met claim
`limitation of “sufficient aeration" even though reference taught away from air entrapment or purposeful aeration.).
`
`[tog (meg;
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`This page is owned by Patents.
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`Last Modified: 03/27/2014 10:10:33
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`http ://www.uspto. gov/web/offices/pac/mpep/s2 1 31 .html
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`6/12/2014
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`I
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`DMC Exhibit 2099_004

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