广东省贸易摩擦应对综合服务平台
（海外知识产权）

In a precedential opinion issued on March 4, 2025, in Restem, LLC v. Jadi Cell, LLC, No, 23-2054, the U.S. Court of Appeals for the Federal Circuit affirmed the PTAB’s claim construction and ruling that product-by-process claims directed to making a specific type of stem cell were not invalid as inherently anticipated after the claim scope had been narrowed during prosecution. The court further affirmed the PTAB’s determination that the prior art process did not inherently teach the claimed product, despite allegedly teaching all of the claimed process steps.

在2025年3月4日发布的一份判例意见中，在“Restem, LLC诉Jadi Cell, LLC”（案号：23-2054）一案中，美国联邦巡回上诉法院确认了美国专利审判和上诉委员会（PTAB）对权利要求的解释以及相关裁决，即针对制造特定类型干细胞的“以制备方法界定产品的权利要求”（product-by-process claims），在专利审查过程中权利要求范围被限缩后，并不因存在固有预期而无效。法院进一步确认了美国专利审判和上诉委员会（PTAB）的判定，即尽管据称现有技术工艺教导了权利要求中所有的工艺步骤，但现有技术工艺并非必然揭示了权利要求所涉及的产品。

1.给从业者的启示

    在专利审查过程中，默许审查员就权利要求范围所做的明确陈述，可能会有效地缩小权利要求术语的范围，即便专利说明书对该术语给出了明确且更宽泛的定义。

对“以制备方法界定产品的权利要求”进行有效性分析时，重点在于最终产品，而非制造该产品的工艺，因为即使旧产品是通过新的工艺制造出来的，它也不具备可专利性。另一方面，侵权判定则要求同时满足所主张的工艺和最终产品的相关要求。

2.干细胞专利和PTAB程序

Restem appealed from an unsuccessful inter partes review final written decision finding that the challenged claims of Jadi Cell’s U.S. Patent No. 9,803,176 (“’176 patent”) were not unpatentable. Representative claim 1 of that patent is directed to stem cells with specific cell markers obtained from the subepithelial layer (“SL”) of mammalian umbilical cord tissue. The claimed “cell” is made by a two-step process and must express at least three cell markers selected from a claimed list and it must also not express at least six specified cell markers selected from a second claimed list. Restem challenged the ’176 patent claims under the theory that they are inherently anticipated or alternatively rendered obvious by the prior art.

Restem公司就一项未成功的多方复审最终书面决定提起上诉。该决定认定，Jadi Cell公司的美国专利第9,803,176号（“’176号专利”）中受到质疑的权利要求并非不具备专利性。该专利的代表性权利要求1涉及从哺乳动物脐带组织的上皮下层（“SL”）中获取的带有特定细胞标志物的干细胞。所主张的“细胞”是通过一个两步流程制造出来的，并且必须表达从所主张的列表中选取的至少三种细胞标志物，同时也一定不能表达从第二个所主张的列表中选取的至少六种特定细胞标志物。Restem公司依据 “’176号专利”的权利要求因存在固有预期，或者另外因现有技术而明显不具备专利性” 这一理论，对该专利的权利要求提出了质疑。

3.因申请人默认审查员意见而导致权利要求范围被缩小

Restem’s first argument was that the PTAB incorrectly construed the claimed “placing” step recited in the limitation “placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate” by importing additional process steps from the specification. The court disagreed, holding that the PTAB had only discussed additional process steps, not to incorporate them into its claim construction, but as part of the factual findings distinguishing the prior art from the claimed process while assessing Restem’s inherent anticipation position.

Restem的第一个论点是，PTAB错误地解释了权利要求中“放置”步骤，该步骤在“将哺乳动物脐带组织的上皮下层与生长基质直接接触放置”这一限定条件中有所记载，因为PTAB从专利说明书中引入了额外的工艺步骤。法院对此并不认同，认为PTAB只是讨论了额外的工艺步骤，并非将其纳入对权利要求的解释中，而是在评估Restem公司关于固有预期的立场时，将其作为区分现有技术与权利要求中所述工艺的事实认定的一部分。

Similarly, the court affirmed the PTAB’s implicit construction of the claim term “isolated cell” as “a cell population.” Relying on the specification’s express lexicography, Restem argued that “an isolated cell” need not be “a cell population” where the specification states, “[a]s used herein, the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Despite this definition, the court found the “isolated cell” term was narrowed during prosecution. The specification and examiner repeatedly described the invention as a “cell population,” including in the Notice of Allowance. The “applicant’s acquiescence to the examiner’s clear statements regarding claim scope,” here in the form of references to “cell population,” narrowed the claim scope despite the specification’s broader and express definition of that claim term.

同样地，法院确认了PTAB对权利要求术语“分离的细胞”默示解释为“细胞群”这一做法。Restem公司依据专利说明书中明确的词义解释，辩称“分离的细胞”不一定是“细胞群”，因为说明书中指出：“如本文所用，术语‘分离的细胞’是指已从哺乳动物脐带的上皮下层分离出来的细胞。” 尽管有这样的定义，法院仍认定“分离的细胞”这一术语在专利审查过程中被缩小了范围。专利说明书和审查员反复将该发明描述为“细胞群”，包括在专利授权通知书中也是如此。“申请人对审查员关于权利要求范围的明确陈述的默许”，在这里以提及“细胞群”的形式体现，尽管专利说明书对该权利要求术语有更宽泛且明确的定义，但这仍缩小了权利要求的范围。

4.基于产品而非工艺确认“以制备方法界定产品的权利要求”不存在固有抵触情况

The court then affirmed the PTAB’s finding of no inherent anticipation of the ’176 patent’s product-by-process claim. Product-by-process claims are those where the product is defined, at least in part, in terms of the process by which it is made. In this case, claim 1 specifies a two-step process of “placing a subepithelial layer of a mammalian umbilical cord tissue in direct contact with a growth substrate; and culturing the subepithelial layer . . .” When determining the validity of a product-by-process claim, “the focus is on the product and not on the process of making it, because an old product is not patentable even if it is made by a new process.” Restem was faulted for improperly trying to shift the analysis away from whether the prior art discloses the claimed product to whether the prior art discloses the claimed process. In contrast, determining infringement of a product-by-process claim requires focus on both the claimed process and the product itself. Thus, where the record did not establish that the final product made by the allegedly anticipating prior art process would have “inevitably” possessed the claimed cell marker expression profiles of claim 1, Restem failed to prove inherent anticipation.

随后，法院确认了PTAB的判定，即’176专利中“以制备方法界定产品的权利要求”不存在固有抵触情况。“以制备方法界定产品的权利要求”，是指至少部分根据产品的制造工艺来对产品进行定义的权利要求。在本案中，权利要求1规定了一个两步流程：“将哺乳动物脐带组织的上皮下层与生长基质直接接触；并培养该上皮下层……” 在判定“以制备方法界定产品的权利要求”的有效性时，“重点在于产品本身，而非制造产品的工艺，因为即使一件旧产品是通过新的工艺制造出来的，它也不具备可专利性。” Restem公司受到了批评，因为它不恰当地试图将分析重点从现有技术是否披露了权利要求所涉及的产品，转移到现有技术是否披露了权利要求中的工艺上。相比之下，判定“以制备方法界定产品的权利要求”是否构成侵权，需要同时关注权利要求中的工艺以及产品本身。因此，由于记录中并未证实据称构成抵触的现有技术工艺所制造出的最终产品“必然”具备权利要求1中所要求的细胞标志物表达特征，Restem公司未能证明存在固有抵触情况。

In addition to clarifying the validity analysis for product-by-process claims, this case serves as a useful reminder that acquiescence to the Examiner’s stated understandings of scope during prosecution can limit the issued claims, for better or worse.

除了阐明对“以制备方法界定产品的权利要求”的有效性分析外，本案也起到了有益的提醒作用：在专利审查过程中，默许审查员对权利要求范围所表达的理解，无论好坏，都可能会对已授予的权利要求构成限制。