By Ramya Possett & James G. McEwen[1]
Background
Traditionally, claim interpretation has differed during a patentability analysis, when the claim is an application being examined, and a validity analysis, when the claim is patented and being analyzed during an infringement action. The reasons for this difference are understood and accepted in the art, and have been espoused by both the courts and the Patent Office as justified and reasonable. However, for purposes of preserving the public notice function of the claim, the validity and infringement analysis have generally been consistent since it makes little sense to narrowly interpret a claim for purposes of infringement while broadly interpret the claim for purposes of validity. Moreover, while the patentability analysis has generally given the examiner more leeway in rejecting claims than might be afforded under the validity analysis, the patentability analysis will generally track the claim interpretation given during subsequent litigation so as to allow the applicants to obtain the broadest coverage for their new and non-obvious inventions while still putting the public on notice of what was invented. Thus, this difference in claim interpretation was not designed to require an applicant to give up substantial amounts of claim scope in order to obtain a patent merely because the claim was analyzed by an examiner as opposed to a judge. As will be explained in below, in light of the Federal Circuit’s decision in Abbott Labs v. Sandoz, 90 USPQ2d 1769 (Fed. Circ. 2009) (en banc as to product by process issue), the Federal Circuit appears to have advocated a much larger difference between interpretation during litigation and examination for one special category of claims: those having product by process limitations.
Examination and the Broadest Reasonable Interpretation Standard
During the examination process, the broadest reasonable interpretation standard has been established for interpreting patent claims for patentability. Courts and the MPEP have repeatedly endorsed this standard, for example, in In re American Academy of Science Tech Center, 70 USPQ2d 1827, 367 F3d 1359 (Fed. Cir. 2004). Here, the Court held that patent claims construed during reexamination should be given their broadest reasonable interpretation consistent with specification, and should be read in light of specification as it would be interpreted by person of skill in art. Id. at 1830. Giving claims their broadest reasonable construction serves the public interest by reducing the possibility that the claims, when issued, would be given a broader scope than is justified. Id. The Court noted that construing the claims broadly was not unfair to patentee or patent applicant, who has ample opportunity to amend claims to obtain more precise coverage. Id. By approaching claim interpretation in this manner, the patent applicant and the Patent Office have the opportunity to enter into a dialogue that enables each to come to an agreement of the scope of the invention as portrayed by the claims.
As such, the justification for more broadly construing claims during examination is that applicants can still amend the claims to clarify the meaning in order to ensure that one of ordinary skill in the art, when confronted with two reasonable interpretations, would come to the correct conclusion. In this manner, the examiner is allowed to wordsmith, and force the applicant to clarify the claims where one of ordinary skill in the art might reasonably conclude that the claims are broader than would be justified under 35 U.S.C. §§101, 102, 103 and 112.
Person of Ordinary Skill Analysis
The person of ordinary skill standard has been utilized in claim interpretation for validity analyses. The Federal Circuit set out a widely utilized methodology explaining how to interpret claims in Phillips v. AWH Corp. Phillips v. AWH Corp., 415 F.3d 1303, 1312-19 (Fed. Cir. 2005) (en banc). As explained by the Federal Circuit in Felix v. American Honda Motor Co., “the ordinary and customary meaning of undefined claim terms as understood by a person of ordinary skill in the art at the time of the invention” is relied upon for claim interpretation. Felix v. American Honda Motor Co., 90 USPQ2d 1524 (Fed. Cir. 2009). Quoting from Phillips, the Federal Circuit asserted in Felix v. American Honda Motor Co. that “[T]he court looks to those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean. Those sources include the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.”Id. at 1314 (internal quotation marks and citations omitted). Thus, the claim interpretation turns on the public record of the case as understood by someone of ordinary skill in the art.
By making the claims, specification and prosecution history paramount in determining claim scope and taking into account the state of the art according to one of ordinary skill in that art, courts recognize the importance of understanding what property rights the inventor acquired from the patent office when his or her patent issued. By enabling a dialogue between the inventor and the patent examiner, the patent office acknowledges the importance of establishing an agreement as to the bounds of the invention. Thus, although the scope of claim interpretation differs between the patentability and validity analyses of the patent claims, the end goal of that interpretation remains the same: to create recognizable property rights whose limits can be ascertained through the negotiations that occurred during their creation and the state of the art that existed during their incipience.
This shared end goal is important for several reasons. First, it enables patent owners to be cognizant of the property rights that they are able to enforce via their patent. The Federal Circuit addressed the import of a clear public record for innovation as well. Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 39 USPQ2d 1573 (Fed. Cir. 1996). The court asserted that the public record of the patentee’s claim (which includes the claims, specifically and file history of the patent) is relied upon by the public. “In other words, competitors are entitled to review the public record, apply the established rules of claim construction, ascertain the scope of the patentee’s claimed invention and, thus, design around the claimed invention.” Id. By creating a clear record and sharing an end goal of claim interpretation, further development and innovation is fostered.
However, unlike examination where the claims can be revised to further clarify the claims, a patented claim cannot be revised easily. Moreover, the patented claim is presumed valid such that the courts are less likely to take positions to invalidate a claim merely due to differences in wordsmithing. Therefore, courts will generally require additional evidence that one of ordinary skill in the art would actually be confused by the claim scope since the remedy of obtaining the wrong claim scope is to invalidate the claim (and deprive the patent owner of a property right).
Effect of the Abbott Labs
The recent en banc decision in Abbott Labs threatens to undermine this common goal regarding the scope of claim interpretation and create confusion as to what property rights exist in pending patents with product-by-process claims and what rights are now obtainable by such claims. Abbott Laboratories v. Sandoz Inc., 90 USPQ2d 1769 (Fed. Cir. 2009). The en banc court in Abbott Labs held that interpretation of product-by-process claims had to take into account the process terms in the claims, regardless of whether the product produced by the process terms in those claims was novel. Id.
Although the patent statute does not explicitly provide for product-by-process claims, the courts have long recognized the appropriateness and necessity of product-by-process claims. See, e.g., Ex parte Painter, 1891 C.D. 200, 200-01 (Comm’r Pat. 1891); In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985); In re Brown, 459 F.2d 531, 535 (C.C.P.A. 1972); In re Steppan, 394 F.2d 1013, 1018 (C.C.P.A. 1967). The USPTO also recognized such claims, for example, in MPEP 2173.05(p). The Federal Circuit reinforced in SmithKline that the purpose of product-by-process claims is to allow inventors to claim “an otherwise patentable product that resists definition by other than the process by which it is made.” SmithKline Beecham Corp. v. Apotex Corp., 78 USPQ2d 1097 (Fed. Cir. 2006) (quoting In re Thorpe, 777 F.2d at 697). The Federal Circuit also recognized that established law prohibits product-by-process claims from validly claiming products already known in the art. SmithKline Beecham Corp. at 1101. However, this narrowing of claim scope would have been consistent with the public record and state of the art at the time the invention was filed. Patents can only be issued for novel inventions, and if the product produced by the product-by-process claim is not novel, a narrower interpretation of the claim would be necessary to capture what was novel in the patent.
With their en banc decision in Abbott Labs, the Federal Circuit expanded that prohibition on old products to instead encompass all products not explicitly defined by the process terms in the product-by-process claim. This holding undermines the initial rationale for allowing such claims to be issued. More significantly, it produces a dichotomy between claim interpretation during the patentability and validity analyses of product-by-process claims that undermines that shared end goal of such analyses.
With the en banc decision in Abbott Labs, product-by-process claims must be construed so as to include the process terms in the claim during litigation. In direct conflict with such an interpretation, the USPTO instructs examiners to consider only the structure implied by the process terms in the claim in MPEP 2113. Thus, the scope of the claims as produced by the two analyses is completely different. The public record created by the examination procedure in the Patent Office is no longer representative of the property rights that are enforceable during the litigation process.
As mentioned above, for patentability, courts and the patent office have agreed that patent claims should be given their broadest reasonable interpretation consistent with the specification, and should be read in light of the specification as it would be interpreted by a person of skill in art. The MPEP quotes In re Zletz to expand upon the reasoning behind the broadest reasonably interpretation standard. MPEP 2106, Section II.C. “During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow…. The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed…. An 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.” MPEP 2106, Section II.C (quoting In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989)). The Patent Office also asserts in MPEP 2111 that “[t]he broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach. MPEP 2111 (quoting In re Cortright, 165 F.3d 1353, 1359, 49 USPQ2d 1464, 1468 (Fed. Cir. 1999)). For product-by-process claims, this rationale is no longer applicable using the instructions set forth in the MPEP. The broadest reasonable interpretation of claims endorsed by the patent office for product-by-process claims is no longer reasonable in light of Abbott Labs since the broadest interpretation available prior to Abbott Labs (that the process is not a limitation) is no longer feasible after Abbott Labs.
The en banc court in Abbott Labs adopted the rule set forth in Atlantic Thermoplastics Co. Inc. to determine the scope of product-by-process claims. Atlantic Thermoplastics Co. Inc. v. Faytex Corp., 24 USPQ2d 1138 (Fed. Cir. 2002). In both Abbott Labs and Atlantic Thermoplastics, the Federal Circuit did not utilize the person of ordinary skill standard. Rather, the Court analyzed previous precedent to reach its decisions. When dealing with patent interpretation, this departure from the widely used standard can prove dangerous due to its implications. In this case, it produced a disparity such that the rights that a patent applicant negotiates during examination are unequivocally not the same rights that he will be able to enforce in litigation.
Further, the benefits of the broadest reasonable interpretation of the claims during examination prove moot by the patent office’s current standards for product-by-process claims. The process terms in those claims which will be widely scrutinized during litigation will only be analyzed during examination to the extent that they provide insight into the structure which they imply. The claims will not be fashioned in a way that is “precise, clear, correct, and unambiguous,” with the uncertainties of claim scope removed. In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989). Instead, only litigation of those claims will provide some understanding of the scope of the invention that the patentee will be able to enforce.
Conclusion
The en banc decision in Abbott Labs has introduced a dichotomy into claim interpretation for patentability and validity purposes that undermines the previously shared goal of both distinct interpretations. Previously, although the scope of claim interpretation differed between the two analyses, the end goal of that interpretation remained the same: to create recognizable property rights whose limits can be ascertained through the negotiations that occurred during their creation and the state of the art that existed during their incipience. With the stark contrast in interpretation between the PTO standard and the new Federal Circuit holding, recognizable property rights whose limits can be ascertained through the public record and the state of art are no longer created when patents with product-by-process claims are issued. Until the Federal Circuit or Supreme Court revisits the interpretation of these claims, the Patent Office should change its operating procedure to again sync its interpretation of product-by-process claims with those of the courts. Otherwise, the property rights created by issued patents with product-by-process will only be ascertained through the litigation of those patents. The implications of continuing to issue such patents with regards to licensing and infringement are alarming.
[1] Ramya Possett is a summer associate at Stein McEwen, LLP, and James McEwen is a partner at Stein McEwen, LLP. The opinions in this article do not represent the official positions of Stein McEwen, LLP.
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