data/2100/s2113.html.txt

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# 2113 Product-by-Process Claims [R-10.2019]

**I.** **PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED
 STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS**"[E]ven though product-by-process claims are limited by and defined by
 the process, determination of patentability is based on the product itself. The
 patentability of a product does not depend on its method of production. If the product
 in the product-by-process claim is the same as or obvious from a product of the prior
 art, the claim is unpatentable even though the prior product was made by a different
 process."  *In re Thorpe,* 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed.
 Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The
 process of making the developer was allowed. The difference between the inventive
 process and the prior art was the addition of metal oxide and carboxylic acid as
 separate ingredients instead of adding the more expensive pre-reacted metal carboxylate.
 The product-by-process claim was rejected because the end product, in both the prior art
 and the allowed process, ends up containing metal carboxylate. The fact that the metal
 carboxylate is not directly added, but is instead produced in-situ does not change the
 end product.). Furthermore, 
 "[b]ecause validity is determined based
 on the requirements of patentability, a patent is invalid if a product made by the
 process recited in a product-by-process claim is anticipated by or obvious from prior
 art products, even if those prior art products are made by different
 processes."
 
 
 *Amgen Inc. v. F. Hoffman-La Roche Ltd.,* 580 F.3d 1340, 1370 n 14, 92
 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also *Purdue Pharma v. Epic
 Pharma,* 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the
 context of an infringement analysis, a product-by-process claim is only infringed by a
 product made by the process recited in the claim. *Id.* at 1370
 (
 "a product in the prior art made by a different process can
 anticipate a product-by-process claim, but an accused product made by a different
 process cannot infringe a product-by-process claim"
 
 
 ). 
 


 The structure implied by the process steps should be considered when
 assessing the patentability of product-by-process claims over the prior art, especially
 where the product can only be defined by the process steps by which the product is made,
 or where the manufacturing process steps would be expected to impart distinctive
 structural characteristics to the final product. See, e.g., *In re
 Garnero,* 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding
 "interbonded by interfusion" to limit structure of the claimed composite and noting that
 terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched"
 are capable of construction as structural limitations). See also *In re Nordt
 Dev. Co.,* 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir.
 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an
 integral structure," and discussing several cases since *Garnero* that
 held "limitations to convey structure even when they also describe a process of
 manufacture"). 
 

**II.** **ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART
 REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS
 DIFFERENCE**"The Patent Office bears a lesser burden of proof in making out a case
 of *prima facie* obviousness for product-by-process claims because of
 their peculiar nature" than when a product is claimed in the conventional fashion.
 *In re Fessmann,* 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974).
 Once the examiner provides a rationale tending to show that the claimed product appears
 to be the same or similar to that of the prior art, although produced by a different
 process, the burden shifts to applicant to come forward with evidence establishing an
 nonobvious difference between the claimed product and the prior art product. *In
 re Marosi,* 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The
 claims were directed to a zeolite manufactured by mixing together various inorganic
 materials in solution and heating the resultant gel to form a crystalline metal silicate
 essentially free of alkali metal. The prior art described a process of making a zeolite
 which, after ion exchange to remove alkali metal, appeared to be "essentially free of
 alkali metal." The court upheld the rejection because the applicant had not come forward
 with any evidence that the prior art was not "essentially free of alkali metal" and
 therefore a different and nonobvious product.). 
 


See also *Ex parte Gray,* 10 USPQ2d 1922 (Bd. Pat.
 App. & Inter. 1989) (The prior art disclosed human nerve growth factor (b-NGF)
 isolated from human placental tissue. The claim was directed to b-NGF produced through
 genetic engineering techniques. The factor produced seemed to be substantially the same
 whether isolated from tissue or produced through genetic engineering. While the
 applicant questioned the purity of the prior art factor, no concrete evidence of an
 nonobvious difference was presented. The Board stated that the dispositive issue is
 whether the claimed factor exhibits any unexpected properties compared with the factor
 disclosed by the prior art. The Board further stated that the applicant should have made
 some comparison between the two factors to establish unexpected properties since the
 materials appeared to be identical or only slightly different.).
 

**III.** **A REJECTION BASED ALTERNATIVELY ON 35 U.S.C. 102 OR 103 FOR PRODUCT-BY-PROCESS
 CLAIMS HAS BEEN APPROVED BY THE COURTS**"[T]he lack of physical description in a product-by-process claim makes
 determination of the patentability of the claim more difficult, since in spite of the
 fact that the claim may recite only process limitations, it is the patentability of the
 product claimed and not of the recited process steps which must be established. We are
 therefore of the opinion that when the prior art discloses a product which reasonably
 appears to be either identical with or only slightly different than a product claimed in
 a product-by-process claim, a rejection based alternatively on either **[section 102](mpep-9015-appx-l.html#d0e302383)** or
 **[section
 103](mpep-9015-appx-l.html#d0e302450)** of the statute is eminently fair and acceptable. As a
 practical matter, the Patent Office is not equipped to manufacture products by the
 myriad of processes put before it and then obtain prior art products and make physical
 comparisons therewith." *In re Brown,* 459 F.2d 531, 535, 173 USPQ 685,
 688 (CCPA 1972). Office personnel should note that reliance on the alternative grounds
 of **[35 U.S.C.
 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** or **[35 U.S.C. 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** does not eliminate the
 need to explain both the anticipation and obviousness aspects of the rejections.
 


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