DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 21-31 are pending.
This application claims priority as a 371 filing of PCT/IB21/61622 (WO 2022/130162) filed 12/13/2021 which claims priority to IN 202011054395 filed 12/14/2020. The certified copy in English has been filed.
Claim Objections
Claims 27 and 29 are objected to because of the following informalities: for grammatical purposes, articles are missing in claim 27 from “sterile membrane” and in claim 29 prior to “supplement composition”. As they are referenced previously, it would be proper to recite –the sterile membrane—and – the supplement composition--.
Claim 30 uses variable references to singular and plural terms. For consistency, the claim should refer to each cell line either in the plural or singular but not vary the numerical status.
Appropriate correction is required.
Claim 28 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 26. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 28 repeats the same limitation already in claim 26.
Claim Rejections - 35 USC § 112, second paragraph
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.
Regarding claim 25, the phrase "but not limited to" renders the claim indefinite because it is unclear what other limitation(s) not recited are part of the claimed invention especially as the claim is not limited to those recited. See MPEP § 2173.05(d). This is true of claim 30.
Claim Rejections - 35 USC § 112 ¶4 rejection
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112 prohibiting improper multiple dependent claims], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 26 recites a range outside of claim 23. Claim 23 limits the pH to 7.2 to 7.5 and hence pH comprising 7.0 and 7.1 is outside of the base claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 21 and 23-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The composition recited in claim 21 is so broad as to read on a large genus of undefined media that is not described in the disclosure. Furthermore, claim 29 requires growth of cell lines wherein these are listed in claim 30 as human breast cancer, human embryonic kidney cells and cervical cancer cell. In claim 31, this supplement leads to increased viability in the range of 90-99% after 72 hours. As to claim 23, the method is drawn to making the supplement composition claimed in claim 21. It simply requires adding components. However, in order to reach the composition of claim 21, the disclosure provides a more precise combination of additions.
The disclosure teaches only a formulation as presented in claim 22 and it is called Clear X9. The composition is made by adding all of the components except growth facto4rs and vitamins in culture grade water. The pH is adjusted to between 7.0 and 7.5 The pH adjusted solution is sterilized and filtered, following this step, the listed growth factors and vitamins are added to the solution aseptically and the liquid medium stored at between 2 and 8o C. The solution was tested with MDA-MB-231, MCF-7 and HEK293 cell lines for cell viability, MTT assay and cell morphology. Clear X( showed improved cell growth over DMEM with 10% FBS.
There is no other indication of a combination of components than that that provides Clear X9 can perform these functions. This is a limited descriptive element wherein the claims broadly and incompletely claim the inventive elements. The claims lack adequate description to link structure to these required functions. The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure. Structural features that could distinguish the compounds of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced but the claims reference these structures with broad generic functional terms that represent a large and diverse genus of elements. To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 21, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pei et al (US 20130040390) and Tam et al (CN 101760442) in view of Kim et al (Free Radical Biology & Medicine 45 (2008) 885–896).
Pei et al teach (Table 2)
a. an inorganic salt in a range of 0.0005-40 wt%- i.e. Calcium Chloride at .02 wt% .
b. an amino acid in a range of 0.01-10 wt%; i.e. leucine or isoleucine at .01 wt
c. a vitamin in a range of 0.0005-1 wt%:; i.e. ascorbic acid at .005 wt%
d. Lipids in a range of 0.06-10 wt%; i.e. tween 80- 0.22 wt%
f. a trace element in a range of 0.0002-3 wt%; phenol red at about 0.0015 wt%
g. an additive in the range of 0.01-35wta%; glucose at about 0.45 wt%
Pei et al teach use of the media for cells such as iPSC. Similar conditions are taught by Tan et al (see ¶0089). The only difference is the concentration of lipids. Tan et al teach use of kidney cells in this media. Growth is explicitly shown by Tan et al (see Figure 4).
However, Kim teaches the reduction of inflammatory redox reactions (see bridging ¶, col 102 page 895) by addition of lutein which is shown effective at 0.02 wt% (MW 569 @ 40 mM, figure 2).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the pigment of Kim in the composition of Tan and Pei. Such a modification would have resulted in a composition encompassed by claim 21. As noted above: 1) using the combination of components listed in claim 21 is known in the art as shown by Tan et al and Pei et al; 2) An improvement is shown by Kim et al to provide protection against ROS by use of pigments. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded media would allow improved growth.
Claims 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (CN 106978390) in view of Sigma Aldrich (Cryostor, 2013, 1 page)
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Wang et al teach methods of making media requiring adjusting pH with 1N HCL or 1N NaOH after which the culture is filtered to sterilize the culture with a 0.22 filter wherein GF and vitamin are subsequently added (see claim 1). Example 3 details the components including inorganic salts, amino acids, lipids, pigments, trace elements and additives.
Storage of media in 2-8oC in the dark is a well-known method (see Sigma).
It would be obvious to use art known methods of storage in order to prepare and maintain media such as that of Wang et al.
Conclusion
Claim 22 is objected to as dependent on a rejected claim.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634