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 Status
Claims 5-9, 11, 13, 16-17, 20-21, and 23-25 are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 5-9, 12-17, and 19, in the reply filed on Nov. 6, 2025 is acknowledged. Claims 5-9, 11, 13, 16-17, 20-21, and 23-25 have been considered on the merits and all arguments were fully considered.
Status of Rejections
Status of the rejections: the previous claim rejections under 35 USC § 112(a) are withdrawn in view of the claim amendments and the claim rejections under 112(b) are withdrawn in view of the claim amendments except as maintained below.
Claim Rejections - 35 USC § 112(b) (maintained)
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 5-9, 11, 13, 16-17, 20-21, and 23-25 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 pre-AIA the applicant regards as the invention.
Claim 9 or 20 recites a medium comprising “LDN-193189 dihydrochloride” (2HCl), which indicates a coordinate salt form LDN-193189 with two HCl, but which is incoherent and unclear as to how this form can remain in this form in an aqueous medium. Claims 13, 16-17, and 24-25 are included in this rejection for depending from indefinite claim 9.
Claims 5-7 and 9 each recites the abandoned trademark “DMEM.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain because the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark DMEM is used to identify/describe a specific cell culture medium defined by the components within and their concentrations or relative abundance. Claims 8, 11, 13, 16-17, 20-21, and 23-25 are included in this rejection for depending from an indefinite claim.
Claims 5-6 and 20 recites the trademarks/trade names “B-27®” and “GS21” to describe a component of a medium, which are each indefinite as explained above. Claims 7-9, 11, 13, 16-17, 21, and 23-25 are included in this rejection for depending from an indefinite claim.
Claim 24 recites the trademarks/trade name “MATRIGEL®” to describe a component of a preparation, which is indefinite, as explained above, a trademark or trade name cannot be used properly to identify any particular material or product.
Response to Arguments
Applicant’s remarks filed regarding the rejections on pg. 12 of the response have been fully considered but not found persuasive. Applicant traverses by arguing DMEM, GS21, B27, and MATRIGEL are conventionally used in the art and are clear to a person skilled in the art. The response points out that DMEM, B27, GS21, and MATRIGEL are available from suppliers, like Thermo Fisher Scientific or Corning Life Sciences, and lists their “main” components. This argument is not found to be persuasive.
The issue is not whether a person skilled in the art is aware of the term in the claim or its exact composition from a commercially available source, e.g., a non-proprietary recipe, but whether the claim limitation is sufficiently definite when referring to the trademark. Although the presence of a trademark in a claim is not improper per se, it is important to recognize that a trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. Thus, a trademark does not necessarily define or describe the goods associated with the trademark. The recitation of a trademark in claim causes claim scope to be uncertain when the trademark cannot be used properly to describe any particular material or product (MPEP 2173.05(u)), such as when the relationship between a mark and the product it identifies is uncertain or arbitrary. For example, the formula or characteristics of a product may change from time to time and yet it may continue to be sold under the same trademark (MPEP 608.01(V)). If a trademark appears in a claim and is not intended as a limitation in the claim, the question of why it is in the claim should be addressed.
The term DMEM (“Dulbecco’s Modified Eagle’s Medium (DMEM)”) regarding a cell culture medium is not defined in the specification. Although the prior art describe all the components of DMEM as a defined media, commercially available DMEM has variants as evidenced by MilliporeSigma (MilliporeSigma, Dulbecco's Modified Eagle's Medium (DMEM) Formulation (2026), e.g., regarding presence/absence of certain amino acids and vitamins). Thus, the presence of the name “DMEM” in the claims causes confusion as to the scope of the claims regarding the definition of the medium. Identification by scientific or other explanatory language is necessary in lieu of any trademark. The specification could be amended to define the term “DMEM” as used in the claims with sufficiently descriptive and definite language as understood in the art at the earliest effective filing date, or alternatively, the term “DMEM” should be replaced in the claims with a generic description as understood in the art at the earliest effective filing date along with amending the specification to provide the same descriptive generic language.
The term “GS21”™ regarding a cell culture medium supplement is not defined in the specification. Although the prior art describes GS21 as completely defined and has never changed during its commercial lifespan, this is not guaranteed forever. Thus, the presence of the name “GS21” in the claims may cause confusion as to the scope of the claims regarding the definition of the supplement. Identification by generic scientific or other explanatory language is necessary as noted for above regarding DMEM.
The term “B27”™ regarding a cell culture medium supplement is not defined in the specification. Although the art describes B-27 (B27) to have originally have a specific definition with precisely 21 components, commercially available B27 has varied in quality and ability to support neuronal cell culture, perhaps due to variability in BSA or transferrin over the years (Chen et al., J Neurosci Methods 171: 239-47 (2008) at pg. 2, para. 2-3; pg. 7, last para., to pg. 8, 3rd para.; pg. 9, 2nd para.). Thus, the presence of the name B27 in the claims causes confusion as to the scope of the claims regarding the definition of the supplement and identification by generic scientific or other explanatory language is necessary.
The specification should be amended to define the term “B27” as used in the claims with sufficiently descriptive and definite language as understood in the art at the earliest effective filing date. Alternatively, the term “B27” supplement should be replaced in the claims with a generic description as understood in the art at the earliest effective filing date along with amending the specification to provide the same descriptive generic language. For example, at the earliest effective filing date, a B27 medium supplement was understood by those of skill in the art to be a commercially available composition comprising 21 defined ingredients: bovine serum albumin (BSA), catalase, glutathione (reduced), insulin, superoxide dismutase, transferrin, triiodo-l-thyronine (T3), L-carnitine, ethanolamine, D-galactose, putrescine, selenite, corticosterone, linoleic acid, linolenic acid, progesterone, retinol (vitamin A), alpha-Tocopherol (vitamin E), alpha-tocopherol acetate, oleic acid, pipecolic acid, and biotin (see Chen at Table 1) or alternatively as recited in Table I of Brewer as having 19 defined ingredients: retinyl acetate instead of retinol and lacking oleic acid and pipecolic acid.
In the instant case, the term “MATRIGEL” is not defined in the instant specification or the literature cited in the response (e.g., Kleinmann). The literature cited provides a description only the major components of merely one example Matrigel® from 1985. However, the art teaches the composition of Matrigel® is not well-defined, shows measurable variability, and can vary with source (see Hughes et al., Proteomics 10: 1886-90 (2010) at Abstract and Fig. 1). Matrigel® properties can vary from batch to batch, and even within a single batch, and cause problems with scientific reproducibility (Aisenbrey and Murphy, Nat Rev Mater 5: 539-51 (2020) at Abstract). Thus, it is the examiner’s position that the components of Matrigel® and their concentrations are not defined in the prior art. Thus, the presence of the trademark term Matrigel® in the claims causes confusion as to the scope of the claims and identification by scientific or other explanatory language is necessary. Thus, the specification should be amended to define the term “MATRIGEL” as used in the claims with sufficiently descriptive and definite language, and the term “Matrigel” should be replaced in the claims with a generic description as understood in the art at the earliest effective filing date along with amending the specification to provide the same descriptive generic language. For example at the earliest effective filing date of the instant application, MATRIGEL® was understood by those of skill in the art to be a commercially available solubilized “basement membrane preparation” extracted from Engelberth-Holm-Swarm (EHS) mouse sarcoma tumors for use in making “reconstituted basement membrane hydrogels” for cell culture applications (Hughes at pg. 1886, right col., para. 1-2).
Note, amendments must be supported by satisfactory showings establishing that the specific nature of the product identified by the trademark as set forth in the amendment was known at the time of filing of the application and possessed according to the written description requirement (MPEP 608.01(V)).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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