DETAILED ACTION
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 .
Claims 1-20 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-7) in the reply filed on 07/30/2026 is acknowledged. Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/30/2026.
Claims 1-7 were examined on their merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
Claim 1 recites the limitation, “coating the said surface with a polymer substantially consisting of a succession of monomers according to the Formula I”.
The disclosure does not define the term “substantially consisting of”, which is mentioned at Paragraph [0066] of the published application:
In other words, preferably, in the context of the present invention (method and composition), the wording “substantially consisting of a succession of monomers according to the formula I” means that more than 60%, preferably more than 65%, more than 70%, more than 75% or even more than 80% of the monomers are those according to the formula I (monomers according to the formula I:total number of the monomers, including those forming the alpha and omega extremities), preferably more than 85, 90, 91, 92, 93, 94, 95, 96, 97, 98% are those according to the formula I.
The “preferably” language indicates that the explanation is drawn to a preferred embodiment/exemplar and is not a limiting definition. Thus, the phrase has been construed as equivalent to “consisting essentially of” consistent with the MPEP at 2111.03, III, which states:
For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.").
Claim Rejections - 35 USC § 112
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 1-4, 6 and 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation, “coating the said surface with a polymer substantially consisting of a succession of monomers according to the Formula I”. As discussed above, this is a non-limiting definition and it is unclear what amount of a succession of monomers are encompassed by the claim such that the metes and bounds of the claim can be readily determined. For purposes of examination, the Examiner has construed the limitation as being met by any amount of a succession of monomers according to Formula I. Claims 2-4, 6 and 7 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
Claims 1-7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites parenthetical subject matter. It is unclear if the material is intended to be part of the claimed invention or not. Claims 2-7 are rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
Regarding Claims 1-7, the phrases "such as", “preferably” and “more preferably” renders the claims indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d). Claim 7 is rejected as being dependent upon rejected Claim 1 and for failing to rectify the indefiniteness thereof.
Claim 4 recites the limitations "the culture medium" and “the detachment medium”. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitations "upon incubation". There is insufficient antecedent basis for this limitations in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Iwai et al. (2013), cited in the IDS.
Iwai et al. teaches selecting a surface (PS/polystyrene plates) (Pg. 9097, Paragraph 2.5);
coating the surface with a polyion complex (PIC) polymer comprising PDMAEMA (Pg. 9097, Paragraphs 2.3, 2.4 and 2.5 and Pg. 9098, Fig. 1B);
and growing rat or human stem cells on the coated surface so that the cells adhere to the coated surface (Pg. 9097, Paragraphs 2.6-2.7), and reading on Claim 1.
With regard to the limitations of Claim 1, that the polymer have any number of a succession of monomers having Formula I, wherein R¹ represents a hydrogen atom or a straight or branched chain alkyl group from 1 to 6 carbon atoms; wherein R² represents a straight or branched chain alkyl group from 1 to 6 carbon atoms, which is substituted by a protonable amino group; wherein the said polymer has a mean pKa between 6.0 and less than 7.5 and a charge density at pH 7.0 between 20 and 50% (number of the positively charged monomers:total number of monomers), the prior art teaches the same polymer as claimed (PDMAEMA, see filed Specification at Pg. 5, Lines 5-14), therefore it must have the same properties and characteristics. See the MPEP at 2112.01, II.
With regard to Claim 5, the PDMAEMA polymer of the prior art is not mixed with any other polymer, therefore it will comprise 100% of the monomers of Formula I.
Claims 1, 5 and 6 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Suzuki et al. (EP 3842519 A1), cited in the IDS.
Suzuki et al. teaches selecting a surface of a container or a substrate (Pg. 24, Claim 9), wherein the substrate may be glass or polystyrene (Pg. 11, Paragraph [0052]);
coating the surface with a polymer comprising monomers of Formula I in a concentration of 100 µg/ml or 0.1 mg/ml (Pg. 11, Paragraph [0048] and Pgs., 23-24, Claim 1, 8 and 9 and Pg. 22, Paragraph [0120]);
and culturing bone marrow derived mesenchymal stem cells (MSC) on the coated surface for a period of time so that the cells adhere to the coated surface (Pg. 22, Paragraphs [0121]-[0122]), and reading on Claims 1, 5 and 6.
With regard to the limitations of Claim 1, that the polymer have any number of a succession of monomers having Formula I, wherein R¹ represents a hydrogen atom or a straight or branched chain alkyl group from 1 to 6 carbon atoms; wherein R² represents a straight or branched chain alkyl group from 1 to 6 carbon atoms, which is substituted by a protonable amino group; wherein the said polymer has a mean pKa between 6.0 and less than 7.5 and a charge density at pH 7.0 between 20 and 50% (number of the positively charged monomers:total number of monomers), the prior art teaches the same polymer as claimed (PDMAEMA, see filed Specification at Pg. 5, Lines 5-14),
therefore, it must have the same properties and characteristics. See the MPEP at 2112.01, II.
With regard to Claim 5, the PDMAEMA polymer of the prior art is not mixed with any other polymer, therefore it will comprise 100% of the monomers of Formula I.
Claims 1 and 3 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Li et al. (2011).
Li et al. teaches selecting a polycaprolactone (PCL) surface (Pg. 1843, Columns 1-2, “Aminolysis…”);
coating the surface with a PDMAEMA polymer having a succession of monomers of Formula I ( Pg. 1843-1844, “Surface-initiated…” and Fig. 1);
culturing mammalian cells (HEK293) on the coated surface for a period of time so that the cells adhere to the coated surface (Pg. 1844, Column 2, “Cell Culture”);
then detaching the cells by contacting with trypsin-EDTA (devoid of calcium) (Pg. 1844, Column 2, “Cell Culture”, 2nd full paragraph), and reading on Claims 1 and 3.
With regard to the limitations of Claim 1, that the polymer have any number of a succession of monomers having Formula I, wherein R¹ represents a hydrogen atom or a straight or branched chain alkyl group from 1 to 6 carbon atoms; wherein R² represents a straight or branched chain alkyl group from 1 to 6 carbon atoms, which is substituted by a protonable amino group; wherein the said polymer has a mean pKa between 6.0 and less than 7.5 and a charge density at pH 7.0 between 20 and 50% (number of the positively charged monomers:total number of monomers), the prior art teaches the same polymer as claimed (PDMAEMA, see filed Specification at Pg. 5, Lines 5-14), therefore it must have the same properties and characteristics. See the MPEP at 2112.01, II.
Claims 1 and 2 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Patrucco et al. (2009), cited in the IDS.
Patrucco et al. teaches selecting tissue-culture polystyrene substrate (Pg. 3132, Column 1, Lines 18-19), wherein the substrate has a negative charge (Pg. 3132, Column 2, Lines 15-16 and Fig. 1);
coating the surface with the polymer PDMAEMA having a succession of monomers of Formula I (Pg. 3132, Fig. 1 and Pg. 3133, Column 1, Lines 5-23 and Column 2, Lines 21-38);
growing murine fibroblasts on the coated surface for a period of time so that the cells adhere to the coated surface (Pg. 3133, Column 2, Lines 46-51), and reading on Claims 1 and 2.
With regard to the limitations of Claim 1, that the polymer have any number of a succession of monomers having Formula I, wherein R¹ represents a hydrogen atom or a straight or branched chain alkyl group from 1 to 6 carbon atoms; wherein R² represents a straight or branched chain alkyl group from 1 to 6 carbon atoms, which is substituted by a protonable amino group; wherein the said polymer has a mean pKa between 6.0 and less than 7.5 and a charge density at pH 7.0 between 20 and 50% (number of the positively charged monomers:total number of monomers), the prior art teaches the same polymer as claimed (PDMAEMA, see filed Specification at Pg. 5, Lines 5-14), therefore it must have the same properties and characteristics. See the MPEP at 2112.01, II.
Claims 1 and 7 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Calejo et al. (2019).
Calejo et al. teaches selecting a surface (glass petri dish) (Pg. 79, Paragraph 2.1);
coating the petri dish surface with polymer according to Formula II (Pg. 79, Paragraph 2.1 and Fig. 1);
and growing human embryonic stem cells on the coated surface so that the cells adhere to the coated surface (Pg. 80, Paragraph 2.5 and Pg. 84, Fig. 6), and reading on Claims 1 and 7.
With regard to the limitations of Claim 1, that the polymer have any number of a succession of monomers having Formula I, wherein R¹ represents a hydrogen atom or a straight or branched chain alkyl group from 1 to 6 carbon atoms; wherein R² represents a straight or branched chain alkyl group from 1 to 6 carbon atoms, which is substituted by a protonable amino group; wherein the said polymer has a mean pKa between 6.0 and less than 7.5 and a charge density at pH 7.0 between 20 and 50% (number of the positively charged monomers:total number of monomers), the prior art teaches the same polymer as claimed, therefore it must have the same properties and characteristics. See the MPEP at 2112.01, II.
With regard to Claim 5, the SBUs polymer of the prior art is not mixed with any other polymer, therefore it will comprise 100% of the monomers of Formula I.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (2011), as applied to Claims 1 and 3 above, and further in view of Causse et al. (US 5,723,109).
The teachings of Li et al. were discussed above.
Li et al. did not teach a method wherein the EDTA detachment medium comprises at least 5mM phosphate, as required by Claim 4.
Causse et al. teaches a method wherein cultured animal cells (human melanocytes) are contacted with a mixture of trypsin and EDTA in a 50mM phosphate buffer (also without calcium), thereby detaching the adhered cells (as evidenced by the use of centrifugal recovery) (Column 6, Lines 15-21).
It would have been obvious to those of ordinary skill in the art to modify the method of Li et al. of detaching adherent cells from a surface by contacting the cells with a trypsin-EDTA solution to use a trypsin-EDTA solution including a 50mM phosphate buffer as taught by Causse et al. because this would provide an additional buffering benefit. Those of ordinary skill in the art would have been motivated to make this modification in order to provide a detachment solution which has buffering capability. There would have been a reasonable expectation of success in making this modification because both references are drawn to the use of trypsin-EDTA to release adherent cells from a substrate.
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 08/12/2026
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